cyrilzakka/clinical-trials huggingface dataset:
Hypokalemia and Intravenous Patient Controlled Analgesia

The increase in stress hormone level and hyperventilation caused by the postoperative pain may contribute to the development of hypokalemia during postoperative period. Therefore, if the postoperative pain is well controlled by the IV-PCA,the plasma potassium level during the postoperative period may be not affected by stress response. The researchers tried to investigate the effect of IV-PCA on potassium regulation during the postoperative period.

Intravenous patient controlled analgesia(IV-PCA) has been widely used to control postoperative pain. The increase in stress hormone level and hyperventilation caused by the postoperative pain may contribute to the development of hypokalemia during postoperative period. Hypokalemia is a risk factor for postoperative arrhythmia. Therefore, if the postoperative pain is well controlled by the IV-PCA, the plasma potassium level during the postoperative period may be not affected by stress response, and the incidence of hypokalemia may be reduced. The researchers tried to investigate the effect of IV-PCA on potassium regulation during the postoperative period.

The researchers divided the patients undergoing laparoscopic cholecystectomy into two groups of IV-PCA group and control group. The researchers compared the plasma potassium concentration from the preoperative to postoperative period.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic cholecystectomy
* ASA class I or II

Exclusion Criteria:

* Any patients with plasma aldosterone, or glucocorticoid disorder including primary hyperaldosteronism, renovascular hypertension, rennin-secreting tumor, salt-wasting renal disease, Cushing syndrome
* Patients with recent exogenous steroid administration or previous diuretics therapy
The Effect of Midazolam on Fluid Responsiveness in Septic Patients

Fluid resuscitation remains the foundation for septic treatment.The evaluation of fluid responsiveness has significance in volume resuscitation for septic shock patients. As the sedative which is commonly used in ICU, Midazolam is supposed to change fluid responsiveness for the pharmacological effect of venodilation. However, the hypothesis has not been certified clinically. In this research, the investigators aim to test the hypothesis that Midazolam can increase fluid responsiveness(using passive leg raising test) in septic shock patients.


Eligibility Criteria:
Patients are included if they meet the following inclusion criteria:

1. Above 18 years old
2. Endotracheal intubated and mechanical ventilated
3. Awake, can communicate with researchers
4. Diagnosed as septic shock. The definition of septic shock was clarified in Year 2001 ACCP/SCCM guidelines
5. Within 24 hours after the EGDT resuscitation goals are achieved
6. Informed consent are signed.

Exclusion Criteria

1. Under 18 years old
2. Intra-abdominal hypertension
3. Central nerves system dysfunction
4. Heart failure and other cardiac dysfunction such as cardiac conduction block,acute coronary syndrome, cardiogenic shock
5. Proof of volume overload or contradiction of fluid infusion
6. Existence of arterial aneurysm, serious valvular disease,extensive peripheral vascular occlusion disease and insertion of artificial pacemaker
Efficacy and Safety of Dapagliflozin When Added to Ongoing Metformin and Evogliptin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

This study evaluates the addition of dapagliflozin in the treatment of type 2 diabetes with metformin and evogliptin combination therapy. Half of subjects will receive dapagliflozin, metformin and evogliptin, while the other half will receive placebo, metformin and evogliptin.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with type II diabetes mellitus aged 19 years or older
2. Patients who had taken metformin(≥1000mg/day) and DPP(dipeptidyl peptidase)-4 inhibitor combination therapy(or complex is allowed) at the same dose for at least 8 weeks prior to the screening visit
3. Patients with fasting plasma glucose≤250mg/dL at the screening visit
4. Patients with 18.5kg/m\^2≤BMI≤40kg/m\^2 at the screening visit
5. Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study

Exclusion Criteria:

1. Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis
2. Patients with a medical history of New York Heart Association(NYHA) class III\~IV heart failure or with congestive heart failure, acute and unstable heart failure
3. Patients with severe infectious disease or severe traumatic systemic disorders
4. Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
5. Patients with galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
6. Patients with moderate to severe stage renal disease, end stage renal disease, dialysis at the time of screening visit
A Safety and Efficacy Study of HPP404 on Weight Loss in Overweight or Obese Subjects

The purpose of this study is to compare the safety and effect of HPP404 versus placebo on body weight in overweight or obese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) from 30.0 to 39.9 kg/m2, for subjects with no additional co morbidities;
* BMI from 27 to 39.9 kg/m2, for subjects with co morbidities (i.e. dyslipidemia defined as high LDL (≥ 160 mg/dL) or high total cholesterol (≥ 240 mg/dL), or subjects with hypertension)

Exclusion Criteria:

* Systolic blood pressure \> 160 mmHg and/or diastolic pressure \> 90 mmHg at the Screening Visit without treatment
* History of use of tobacco or nicotine-containing products 180 days prior to Screening visit
* Subjects with type 2 diabetes or fasting blood glucose concentration ≥ 126 mg/dL
* History of appetite or weight modifying surgeries/procedures
Evaluate the Effectiveness of the Mobile Instant Messaging Intervention

This study explores the caregiving needs of male spouses and develops an instant messaging software intervention to provide effective support. The goal is to help male spouses better adjust to their caregiving roles, reduce psychological stress and emotional distress, and improve overall health.

A randomized controlled trial will be conducted to evaluate the effectiveness of the mobile instant messaging intervention, analyzing its impact on reducing psychological distress and improving the quality of life of male spouses.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older, with a diagnosis of gynecological cancer (including cancers of the cervix, endometrium, fallopian tubes, ovaries, uterus, or vagina), and whose spouse has not been diagnosed with any other type of cancer;
2. The spouse has undergone cancer treatment, including surgery, chemotherapy, or radiotherapy;
3. Clear consciousness and ability to communicate in Mandarin or Taiwanese;
4. Willingness to participate in the study after being informed of the study purpose and procedures.

Exclusion Criteria:

Individuals with psychiatric disorders.
Therapy Optimization in Multiple Sclerosis (MS)

The purpose of this study is to determine if higher compliance and adherence rates to drug therapy for MS result in better health outcomes than lower rates of therapy compliance and adherence.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or older, with a diagnosis of MS.
* Being treated with Glatiramer Acetate (GA) or (IFN)-β
* Receiving therapy from a participating Specialty Pharmacy

Exclusion Criteria:

* Has any contraindication to GA or IFN-β therapy, including pregnancy, trying to become pregnant, or breast feeding during the study
* Has received an experimental drug in the last thirty (30) days other than Fampridine SR (4-aminopyridine or 4-AP)
* Unlikely to be able to participate for the full two years of the study
The Effect of Quantitative EEG Combined With Ultrasound and Sputum Volume on Predicting Weaning Failure

Neurocritical patients often face the need for removal of endotracheal tubes. However, despite following the extubation criteria for general critical ill patients, neurocritical patients still exhibit a higher rate of weaning failure, significantly higher than that of general critical ill patients. The extubation criteria for general critical patients emphasize the assessment of lung conditions. However, neurological critical patients often have less severe lung damage, but factors such as consciousness level and coughing ability may significantly influence extubation. Quantitative EEG serves as an objective tool to reflect consciousness level status, while bedside ultrasound can assess respiratory muscle function. Additionally, sputum volume may reflect the condition of lung condition. Therefore, we believe that combination of these three indicators can better predict the success of extubation for neurocritical patients.


Eligibility Criteria:
Inclusion Criteria:

* Neurocritical patients with endotracheal intubation;
* Successful spontaneous Breathing Trial;
* The patients meet extubation criteria evaluated by clinical physician

Exclusion Criteria:

* Patients whose families have opted for cessation of treatment.
Evaluation of the Psychological Consequences of Complicated Childbirth

Prospective, non-interventional, monocentric, case-control study

The post-traumatic stress state affects up to 6.2% of patients at 2 months post partum.

Emergency cesarean section and rescue hemorrhage are identified risk factors for postpartum stress disorder or postpartum depression.

These complications (emergency cesarean section and hemorrhage of delivery) alter the mother-child relationship and cognitive development of the child.

The experience of an emergency Cesarean section or a haemorrhage of deliverance generates apprehension about a subsequent pregnancy. Some patients abandon a future pregnancy project for fear of reliving these experiences.

Currently, at the southern hospital, the risk factors for developing a state of post-traumatic stress are not sought by the care teams. No specific follow-up is planned for patients who have had an emergency caesarean section or hemorrhage of delivery.

The investigators wish to study the psychological consequences of emergency cesarean section and rescue haemorrhage, the risk factors for post-traumatic stress disorder after emergency cesarean section or hemorrhage of delivery, and their consequences on the mother-child relationship to better identify situations at risk of psychological trauma and provide appropriate care for patients (consultation with a postpartum psychologist).

Eligibility Criteria:
Inclusion Criteria:

* Major patients ;
* Who had hemorrhage of the transfused delivery between 01/01/2015 and 31/12/2017 or an emergency cesarean section between 01/01/2015 and 31/12/2016 or patients who gave birth physiologically paired with age, date of delivery and parity ;
* Patients who did not express their opposition to participate in the study.

Exclusion Criteria:

* Minor patients;
* Patients who do not speak and understand French;
* Major persons subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty.
Kyphoscoliosis Surgery: Blood Conservation and Analgesia

Since the first spinal fusion by Hibbs 1911, yet anesthesia for correction of scoliosis is challenging due to frequently associated co-morbidities, the extensive nature of surgery and liability for many complications. Among the major concerns for anesthesiologists are the pain and bleeding. Scoliosis correction accounts for massive blood loss that may exceed more than half of blood volume. There are many strategies for blood conservation; however sometimes some of them may not be suitable. For analgesia, the most frequently loco regional analgesic techniques in spine surgery are intrathecal, epidural or local infiltration techniques. infiltration data reviled inconclusive and heterogeneous results. Our purpose is to optimize blood conservation and analgesia through anatomically based modification of the infiltration technique.

The most frequently loco-regional analgesic techniques in scoliosis surgery are intrathecal, epidural, caudal morphine, or local infiltrations techniques including ultrasound guided thoracolumbar interfascial plane block. however these techniques possess some limitations in scoliosis surgery. Local anesthetic infiltration was first applied over 35 years ago in lumbar spine surgery as a reliable technique for pain relief. However meta-analysis of data reviled inconclusive and heterogeneous efficacy results.This conflict arise from the differences in the technique and drugs.There are three levels of infiltration; subcutaneous, muscular and perineural. Its timing either pre-incision or post-surgery. Generally the preemptive and deep infiltration offer better analgesia when compared with post-surgical and superficial forms. Different drugs including local anesthetics, epinephrine and adjuvants can be given as a single injection or infusion. Doses and volumes are also different, usually ranging from 10 to 30 ml at a concentration of 0.25% Bupivacaine. the use of epinephrine helps bleeding control Concomitantly, unlike the other techniques, bupivacaine infiltration was combined at three levels in this study; subcutaneous, muscular and neural paravertebral to provide sensory, motor and sympathetic blockade all together. In addition, this drug combination may help to maintain spinal cord perfusion by avoiding deliberate hypotension. The high volume sufficient for proper tissue infiltration combined at three anatomically guided levels for three types of nerves has not been described so far. This research may benefit all spine surgery patients.

Eligibility Criteria:
Inclusion Criteria:

1. Kyphoscoliosis patients subjected for spinal correction.
2. Age 8-18 years.
3. American Society of Anesthesiologists I-II status.

Exclusion Criteria:

1. Patient or parents refusal.
2. Infection at surgical site.
3. Hypersensitivity to amide local anesthetics.
4. Coagulopathy.
5. Blood diseases as sickle cell anemia, hemophilia, idiopathic thrombocytopenic purpura.
6. Sever cardiac, respiratory, renal or hepatic impairment.
7. Presence of communication barrier.
Clinical And Cost- Effectiveness of Allium Sativum Oil (Garlic Oil ) Versus Mineral Trioxide Aggregate in Primary Molars Pulpotomy in Group of Egyptian Children : A Randomised Clinical Pilot Study.

Allium Sativum oil is advocated to prove the capability of new natural products in replacing higher cost pharmacological materials, while achieving the same successful clinical and radiographic long-term results.

One of the most challenging subjects in paediatric dentistry is choosing the ideal pulp medication material that has the required properties such as preserving the vitality of the remaining intact pulp and stimulating its repair. This material should prevent pathological root resorption.Clinical and cost effectiveness trials from different countries are useful to determine which medicament should be advocated in which economic setting . Alternative pulpotomy materials clinically effective as MTA but with lower cost should be studied .

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy children aged from 5- 7 years.
* Children not having antibiotics in the past 14 days.
* Cooperative children.
* Children are having at least two carious asymptomatic second primary molars.

Exclusion Criteria:

* Uncooperative children.
* Immunocompromised children.
* Children with clinical or radiographic symptoms
Intermittent Antimalaria Treatment With SP in African Children

- intermittent preventive treatment with SP in children to evaluate efficacy and safety of this drug combination in children in northern Ghana

* Sulfadoxine and pyrimethamine have long been used for malaria prevention and treatment. In this study, following suggestions of WHO, these drugs are used for intermittent treatment.
* It will be tested if this approach reduces the number of malaria attacks and ameliorates the severity of the disease
* It will also be determined if anemia due to malaria, which is prevalent in northern Ghana, may be reduced
* Moreover, the interaction between red cell polymorphisms such as HbS, HbC, alpha-thalassemia and glucose-6-phosphate dehydrogenase deficiency and SP will be examined

Eligibility Criteria:
Inclusion Criteria:

* informed consent by parents or guardian
* no concomitant serious disease
* age \>2 months

Exclusion Criteria:

* serious allergy or hypersensitivity to sulfonamides or pyrimethamine
* no severe hepatic or renal dysfunction
* serious breach of study protocol
Effect of Shoulder Traction on Size and Relative Position of Internal Jugular Vein to Carotid Artery

Internal jugular vein (IJV) catheterization is frequently performed in infants undergoing major surgery. Although it has been suggested that head rotation increases the degree of overlapping between IJV and carotid artery (CA), IJV catheterization without head rotation is extremely difficult in infants. The aim of the present study is to evaluate whether the caudo-lateral traction of the ipsilateral arm can decrease the degree of overlapping between IJV and CA in infants during head rotation.

Central venous catheterization is frequently performed in pediatric patients undergoing major surgery for fluid management and vasoactive drug therapy. Compared to subclavian vein, internal jugular vein (IJV) is generally preferred for catheterization because of the low incidence of serious complications, such as pneumothorax and hemothorax. However, especially in infants, IJV catheterization is still technically difficult because of the small size of the vein and anatomical variation.

In previous studies, ultrasound guidance and keeping in neutral head position have been recommended to increase the success rate and to decrease the overlap between carotid artery (CA) and IJV, respectively. However, devices for ultrasonography are not always available. Moreover, IJV catheterization without head rotation could be extremely difficult in infants because of relative the larger skull and the smaller neck than those of adults. Therefore, a simple method to relieve the overlap between CA and IJV would be needed.

During head rotation to the contralateral side, the cephalic part of IJV is moved to the same direction. Accordingly, the investigators thought that the counter traction of the caudal part of IJV using the caudo-lateral traction of the ipsilateral arm might relieve the overlap caused from head rotation. Therefore, the investigators evaluated the effect of the caudo-lateral traction of the ipsilateral arm on the overlap between common CA and IJV in infants.

Eligibility Criteria:
Inclusion Criteria:

* infants undergoing elective surgery

Exclusion Criteria:

* subjects with congenital heart disease or mass in head and neck
* Subjects with anatomical malformation of great vessels
* previous central venous access via IJV
Novel Approach to Conduction System Pacing with Use of Ultrasound

Each year, over one million pacemakers are implanted globally using x-rays. Recent developments have been aimed at determining which area of the heart is the best option for lead placement. An area in the septum separating the verticals called the left bundle branch area (LBBA) has previously been identified as a safe and effective area for lead placement. However, as the LBBA location is in the center of the heart, it is impossible to see the entire extent using X-ray. Current practice requires x-ray guidance to estimate the location and pacing parameters to confirm proximity. Implanting in LBBA takes longer procedure times and higher exposure to X-ray radiation for both patients and hospital staff. Over time, radiation poses an increased risk of cancer and other medical issues.

This study will determine if using ultrasound can improve pacemaker lead implantation to the LBBA. Benefits to patients may include fewer attempts and more accuracy in lead deployment, thereby reducing risks and providing improved outcomes. Benefits to healthcare delivery may include reduction in total procedure time, thereby allowing more cases per day to reduce waitlist, and reduced X-ray exposure to staff thereby reducing cumulative effects.


Eligibility Criteria:
Inclusion criteria: Patients meeting the following criteria are eligible for the study:

1. Male or female ≥18 years of age
2. Eligible to have a single or dual chamber pacemaker implanted for LBBAP
3. Confirmed diagnosis of conduction tissue disease
4. The participant can understand the written informed consent/assent, provides signed and witnessed written informed consent/assent, and agrees to comply with protocol requirements.
5. Good imaging quality determined on routine echocardiography

Exclusion Criteria: Patients will be excluded if any one of the following criteria is met:

1. Any medical or psychiatric condition that, in the investigator's opinion, could jeopardize or compromise the participant's ability to participate in the study.
2. Any acute active malignancy requiring treatment or life expectancy is deemed less than 1 year.
3. Clinically significant disease that increases their risk of bleeding (hematological disorders, dialysis patient - anticoagulation does not apply)
4. History of alcohol or drug (other than caffeine) use disorder within 12 months of pacemaker implantation.
5. Hepatic impairment defined as ALT/AST \>3 × ULN and/or total bilirubin \>ULN, at Screening.
6. The participant has any clinically significant illness, in the opinion of the investigator, prior to their pacemaker implantation
7. Any other issues which, in the opinion of the investigator, will make the participant ineligible for study participation.
8. CRT and ICD implants.
9. Pregnancy or female of childbearing age (if negative pregnancy test not provided).