cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety of a Single Intravenous (IV) Dose of Orbactiv (Oritavancin) in Participants on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

This was a Phase 4, multicenter, open-label safety study of a single 1200 milligrams (mg) IV infusion of oritavancin in adult participants on chronic warfarin with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens.

An additional group of participants with ABSSSI, who were not on concomitant warfarin therapy, were also enrolled to obtain additional information following a single dose of oritavancin administration.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ABSSSI (wound infection, cellulitis/erysipelas, or cutaneous abscess) suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy
* Must be currently being treated with chronic warfarin therapy\* \*Participants in the non-warfarin group are not required to be on chronic warfarin therapy.

Exclusion Criteria:

* Known or suspected bacteremia, sepsis or refractory shock
* Participants who are likely to need treatment with IV heparin within 48 hours
* Significant or life-threatening condition
* Women who are pregnant or nursing
* Receiving chronic systemic immunosuppressive therapy such as chemotherapy or prednisone
* CD4 count \<200 cells/mm\^3 in participants with known human immunodeficiency virus or acquired immune deficiency syndrome
* Neutropenia
Effect of Coenzyme Q10 on Diabetic Children

Determine the effect of Coenzyme Q10 on random blood sugar and glycosylated haemoglobin

Type 1 diabetes mellitus is an autoimmune disease that leads to destruction of insulin producing pancreatic Beta cells.

Individuals with type 1 diabetes requires life long insulin replacement with multiple daily insulin injection. daily,insulin pump therapy or the use of an automated insulin delivery system.

without insulin ,diabetic ketoacidosis develops and is life threatening.

In addition to insulin Therapy ,glucose monitoring with a continuous glucose monitor and a blood glucose monitor if continuous glucose monitor is unavailable is recommended .

Coenzyme Q10 supplementation has beneficial effects on glycemic control especially in diabetes , and 100-200 mg per day of Co Q10 could achieve the greatest benefit which could provide a basis for the dietary guidelines of Co Q10 in patients with glycemic disorders .

Co Q10 with a known antiinflammatory and antioxidant has beneficial effects on endothelial function and therefore minimize the microvascular and macrovascular complication in patients with type 1 diabetes mellitus.

Administration of Co Q10 for 3 months in type 1 diabetes mellitus in pediatric patients was will tolerated but had no favorable effect on endothelial dysfunction or metabolic parameters .

Co Q10 in addition to improving the metabolic hyperglycemia , it improve Hb A1c and the lipid profile.

patients with type 1 diabetes , especially poorly controlled had elevation of plasma vitamin E and coenzyme Q10 levels and decreased platelet redox status of coenzyme Q10 which may be an indicator of increased oxidative stress ,so Co Q10 has an antioxidant effects.

Researches on this topic are limited on pediatrics and investigators search for it and will see the result.(clinical trial)

Co Q10 is present in the forms of soft gel capsules ,oral spray , hard gel capsules and tablets .

Co Q10 approved from age of 2 years old to 18 years old .

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed as type 1 diabetes mellitus from age of 2 years old to 18 years old with diabetes mellitus of duration at least 1 year.

Exclusion Criteria:

* - patients diagnosed as diabetes mellitus less than 2 years old .
* patients with diabetes mellitus of duration less than 1 year.
* patients diagnosed as type 1 diabetes mellitus with Thyroid or celiac diseases.
* other types of hyperglycemia rather than Type 1 diabetes mellitus.
Bespoke vs Standard Instrumentation in TKR

Total knee replacements are operations that are offered to patients who have severe arthritis pain that is affecting daily activities that is no longer controlled with painkillers. The operation will replace the worn joints with metal implants and a plastic spacer. Total knee replacements are successful operations in the vast majority of patients. However, a small minority of patients are not entirely satisfied with the outcome of their knee replacement. Researchers are studying whether the precise positioning of the implant has an effect on the outcome.

This study will look at whether patient-specific instrumentation improves implant position and if it leads to improved patient function so that we know what to recommend in the future.


Eligibility Criteria:
Inclusion Criteria:

* Patients with osteoarthritis of the knee which is sufficiently symptomatic to require knee arthroplasty as assessed by their consultant orthopaedic surgeon

Exclusion Criteria:

* Patients with inflammatory arthropathy, patients requiring bone augmentation, patients with ligament incompetence or valgus deformity \>5 degrees.
Safety and Efficacy of Maintenance of Etomidate in General Anesthesia

This study was designed to use etomidate combined with sevoflurane intravenously to maintain anesthesia process under the monitoring of BIS. Propofol was used as the controls. Blood pressure and heart rate were recorded during operation. The VAS pain score was observed after surgery.To investigate whether this program can better maintain intraoperative hemodynamic stability, improve the quality of recovery, and reduce the incidence of postoperative adverse reactions.


Eligibility Criteria:
Inclusion Criteria:

* 18 ≤age≤65;
* Types of surgery: laparoscopic gynecological surgery, laparoscopic gastrointestinal surgery, thoracoscopic radical lung cancer surgery;
* 1 h ≤ operation time ≤ 3 h;
* ASA grade I\~III;
* BMI of 18.5\~29.9 kg/m2 \[BMI= weight (kg)/height (m) 2\] (2013 American guidelines for the Management of Overweight and Obesity in Adults);
* In accordance with ethics, the patient voluntarily took the test and signed the informed consent.

Exclusion Criteria:

* Cerebral vascular accident, such as stroke, transient ischemic attack (TIA), etc. within 3 months;
* Severe abnormal liver and kidney function (severe abnormal liver function: ALT, AST, ALP, total bilirubin, one of which is more than 2 times the upper limit of normal value. Severe renal dysfunction: creatinine \> 2 times upper normal);
* Patients with diabetic complications (diabetic ketoacidosis, hyperotonic coma, various infections, macrovascular disease, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.);
* Unstable angina pectoris or myocardial infarction occurred within 3 months;
* Preoperative blood pressure ≥160/100 mmHg ( ≥ Grade 2 hypertension, 2020 ISH Hypertension Guidelines);
* Identified/suspected abuse or long-term use of narcotic sedatives and analgesics; •Taking hormones or other immunosuppressive agents for more than 10 days within half a year, or having a history of adrenocortical suppression or immune system diseases;
* Hypothyroidism;
* Patients with a history of asthma;
* Those who were reoperated within 3 months;
* Having contraindications or allergies to test drugs and other narcotic drugs;
* Patients enrolled in other studies within 30 days.
Glycemic Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus

This will be a randomized, cross-over design. Subjects will be randomized to one of six interventions on six separate study days, 1 week apart.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-75 yrs
* Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide (Glucotrol/Glucotrol XL) and glyburide (DiaBeta, Micronase, Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alpha-glucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg
* Hematocrit levels within normal limits

Exclusion Criteria:

* Abnormal thyroid function
* Creatinine \>2.0 mg/dL
* Potassium \<3.5 mEq/L
* Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
* Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
* Unable to give informed consent or follow instructions
* Current insulin therapy or insulin therapy within the past month
* Patient who are pregnant
* Allergies to milk, soy or any component of the test product
* Patient who in the Investigators assessment cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial.
* Patients with Anemia
Anterior Knee Pain After Tibial Nailing

Anterior knee pain (AKP) is a common complication following intramedullary (IM) nailing of a tibial shaft fracture. The purpose of this prospective study was to determine if there is an association between AKP and nail position. The investigators have analyzed postoperative outcome results and the possible relationship between AKP according to the visual-analog scale (VAS) scale, and nail position marked as a distance from the tip of the nail to the tibial plateau (NP) and tuberositas tibiae (NT), measured postoperatively on L-L knee X-rays.

The aim of this study was to determine the possible relationship between anterior knee pain (AKP) and nail position marked as a distance from tip of nail to tibial plateau (NP) and to the tuberositas tibiae (NT).

We evaluated postoperative outcome results of 50 patients in the last 3 years with healed fractures initially treated with intramedullary (IM) reamed nails with 2 or 3 interlocking screws on both parts of the nail and with the use of medial peritendinous incision for nail entry portal. Patients marked a point on the visual analog scale (VAS) that corresponded to the level of postoperative AKP felt. Two groups of patients were formed on the basis of AKP (pain level was neglected): groups A and B, with and without pain, respectively.

We found that the difference between the two groups concerning NP measurements was statistically significant, but not concerning NT measurements (P \< 0.05). Patients were classified by pain with high accuracy (98%) according to a classification tree.

We conclude that the symptoms of AKP did not appear if the tip of the nail position was more than 6.0 mm from the NP and more than 2.6 mm from the NT. However, for better evaluation of these results it will be necessary to examine more postoperative patients with AKP.

Eligibility Criteria:
Inclusion Criteria:

* tibial shaft fractures
* fracture treatment with intramedullary nailing with 2 or 3 interlocking screws on both ends of the nail

Exclusion Criteria:

* amputated legs
Intrathecal Morphine vs. US-Guided Bilateral Posterior Quadratus Lumborum Block in Cesarean Section

In this study, it was aimed to evaluate the effects of intrathecal morphine and posterior quadratus lumborum block (QLB2) on postoperative acute pain scores and opioid consumption in the first 24 hours after cesarean section.

Postoperative acute pain following a cesarean section is sharp, well-localized, and highly intense. An ideal pain management approach after a cesarean section should provide high-quality analgesia with minimal side effects and facilitate the mother's rapid return to daily activities. Different options for pain control include central blocks, peripheral blocks, and systemic medications.

Intrathecal morphine (ITM) administration is a widely used approach for post-cesarean pain management both globally and in our clinic. However, it can reduce patient satisfaction due to side effects such as nausea, vomiting, and itching. On the other hand, the Quadratus Lumborum Block (QLB), a type of peripheral block, has proven analgesic efficacy in controlling acute postoperative pain following a cesarean section. The aim of this study is to examine and compare the analgesic efficacy of intrathecal morphine (ITM) and Posterior Quadratus Lumborum in the management of acute postoperative pain after a cesarean section.

This study is a single-center, double-blind, prospective observational study.

Patients will be divided into 2 groups.

Group 1: The group receiving intrathecal morphine (ITM)

Group 2: The group receiving Posterior Quadratus Lumborum Block

In elective cesarean section cases under spinal anesthesia, the patient group receiving ITM and posterior QLB will be evaluated for obstetric general well-being during the first 24 hours and at discharge. Total morphine consumption in the first 24 hours, Pain scores (NRS) at rest and during movement, presence of nausea-vomiting and itching, patient satisfaction and any potential side effects will be recorded through follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant for at least 37 weeks
* Aged between 18 and 45
* ASA (American Society of Anesthesiologists) physical status score II
* Patient planned for elective cesarean section under spinal anesthesia
* Patient receiving QLB-II block or intrathecal morphine

Exclusion Criteria:

* ASA score of III or IV.
* Planned cesarean section under general anesthesia.
* Requirement for conversion to general anesthesia after failed spinal anesthesia.
* Contraindication to spinal anesthesia and regional anesthesia techniques.
* BMI greater than 35 kg/m².
* History of opioid use disorder or opioid use for more than 4 weeks.
* Inability to assess pain scores.
* Pregnancies of less than 37 weeks gestation.
* History of allergy to local anesthetics and systemic opioids.
* Patient refusal
Clinical Study of Aldurazyme in Patients With Mucopolysaccharidosis (MPS) I

This study is being conducted to demonstrate the safety and clinical efficacy of Aldurazyme treatment in MPS I patients


Eligibility Criteria:
Inclusion Criteria:

* The patient had a documented diagnosis of MPS I confirmed by measurable clinical signs and symptoms of MPS I and a fibroblast or leukocyte alpha-L-iduronidase enzyme activity level of less than 10% of the lower limit of the normal range of the measuring laboratory.
* Female patients of childbearing potential had a negative pregnancy test (urine-beta-human chorionic gonadotropin (hCG)) at baseline (all female patients of childbearing potential and sexually mature male patients were advised to use a medically accepted method of contraception throughout the study).
* The patient was capable of standing independently for 6 minutes and walking a minimum of 5 meters within 6 minutes.
* The patient was capable of performing a reproducible FVC maneuver.
* The patient had a baseline FVC value that was less than or equal to 80% of the patient's predicted normal FVC value based on polgar predicted values for standing height for children 5 through 7 years of age and the Hankinson predicted values for ages 8 and above.

Exclusion Criteria:

* The patient had undergone a tracheostomy.
* The patient had previously undergone a bone marrow transplantation.
* The patient was pregnant or lactating.
* The patient has received an investigational drug within 30 days prior to study enrollment.
* The patient had a medical condition, serious intercurrent illness, or other extenuating circumstance that could have significantly interfered with study compliance including all prescribing evaluations and follow-up activities.
* The patient had a known hypersensitivity to rhIDU or to components of the active or placebo test solutions.
Oral Rehydration Therapy in Children With Mild to Moderate Dehydration

The purpose of this study is to determine parental attitudes towards oral rehydration therapy for children with mild to moderate dehydration.


Eligibility Criteria:
Inclusion Criteria:

* Parents of dehydrated children aged 0-18

Exclusion Criteria:

* Child with severe dehydration
* Child with chronic disease causing dehydration
Orthotic Use for Chronic Low Back Pain

The goal of this randomized clinical study is to assess pain and dysfunction in 225 volunteer subjects who have chronic low back pain.

The hypothesis of this study is that custom-made shoe will improve patients' low back pain and dysfunction. Additionally, custom-made shoe orthotics plus chiropractic treatment will further improve patients' low back pain and dysfunction while maintaining that improvement during the one year study follow-up period.

Specific Aims:

1. To determine the changes in perceived pain levels (Numeric Pain Rating Scale) and dysfunction (Oswestry Disability Index) in patients with chronic low back pain after six weeks of custom-made shoe orthotic use with or without chiropractic care as compared to no care.
2. To determine the changes in perceived pain levels and dysfunction in patients with chronic low back pain after twelve weeks of custom-made shoe orthotic use.
3. To determine the changes in perceived pain levels and dysfunction at 3, 6, and 12 months following the 12 week treatment period.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old
2. Subjects must be symptomatic with current pain between T12 and the SI joints with or without radiating pain at an average score of 4 or higher on the NPRS scale
3. Symptoms must have been present for at least three months

Exclusion Criteria:

1. Use of custom-made orthotics in the past 6 months
2. Ongoing active conservative care (such as physical therapy or chiropractic care) for the low back, leg, or foot received in the past 6 months (excluding the use of oral medications or daily at-home exercises for general well-being).
3. Current or future litigation for any healthcare concern
4. Not fluent or literate in the English language. We will not be able to provide multiple translators within this study
5. Brain disorders (e.g., dementia, Alzheimers Disease , etc.) that would lead to difficulty in questionnaire completion
6. Chronic pain other than low back pain, such as fibromyalgia or multiple sclerosis
7. Clinically significant chronic inflammatory spinal arthritis
8. Spinal pathology or fracture
9. Progressive neurologic deficits due to nerve root or spinal cord compression, including symptoms/signs of cauda equina syndrome
10. History of bleeding disorder
11. Known arterial aneurysm
12. Previous lumbar spine surgery
13. Severe skeletal deformity of the foot
14. Peripheral neuropathy due to disorders such as diabetes
15. Low back pain that is not reproducible
16. Current pregnancy
17. Other conditions that may affect the subjects' ability to participate throughout the duration of the study or exclude patients from participation in the study, including contraindications to orthotic use or chiropractic spinal manipulations
Enhanced Community First Responder System Evaluation in Singapore

The rise in out-of-hospital cardiac arrest (OHCA) cases in Singapore highlights the need for effective bystander cardiopulmonary resuscitation (BCPR). Despite many lay responders performing CPR, survival rates with good neurological outcomes have not significantly improved, prompting research into the quality of CPR as a critical factor. The study by Gallagher EJ et al. showed a significant survival improvement with high-quality CPR.

To address this, the Unit of Pre-hospital and Emergency Research (UPEC) trained thousands of community first responders (CFRs) in simplified CPR techniques using hands-only and DA-CPR methods. A significant innovation is the CPRcard®, developed by Laerdal in Norway, which offers real-time feedback on the quality of chest compressions. However, only 36% of CFRs using the CPRcard® achieved the desired compression standards, indicating room for improvement.

The study proposes enhancing CFR support with information communication technology (ICT), enabling two-way audio and one-way video communication between CFRs and dispatchers. This aims to reduce stress among responders, increase their willingness to engage with OHCA alerts, and improve CPR quality.

The clinical trial in Singapore will compare the current system against the enhanced CFR support system (eCSS), focusing on the real-time relay of CPR performance data, communication ease, and implementation factors. The high-quality CFR and OHCA registries in Singapore provide a robust setting for this research, aiming to enhance CPR delivery and improve OHCA outcomes through technology and real-time support.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old and above
* SCDF registered CFRs
* TDDs with an active account of myResponder® app on their mobile phones

Exclusion Criteria:

* The CFRs who are pregnant
* Experiencing any serious physical Conditions
* Mental Health Conditions
Popliteal Block for Lower Limb Angioplasty

Endovascular revascularization is an effective procedure in treatment of chronic critical limb ischemia. The less invasive procedure in high risk patients produce the benefit to the patients. However, some of the patients cannot tolerate local anaesthesia. These patients need sedation or even general anaesthesia, which increase unnecessary risk to the patients. This study is conducted to evaluate the benefit of popliteal sciatic nerve block or popliteal block compare to sedation in critical limb patients undergoing angioplasty.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 20 year-old with chronic ischemic limb pain
* Scheduled for peripheral angioplasty under monitor anaesthesia care
* Expected timing of procedure not more than 3 hours

Exclusion Criteria:

* Age less than 21
* Cannot cooperate with the staff
* Having pain in other areas or both legs
* Contraindicate for nerve block
* Allergy to local anesthetic drugs or sedative drugs
Role of REM Sleep Alterations in Post Operative Delirium After Cardiac Surgery

Acute confusional states known as delirium frequently occur in Intensive Care Units (ICU), mostly after cardiac surgery, leading to serious consequences. Sleep deprivation has been described in ICU patients and is considered as a risk factor for delirium but its role is still unknown. It is therefore essential to identify whether sleep deprivation and more specifically REM sleep alterations could facilitate occurence of delirium in ICU.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had a cardiac surgery with extracorporeal circulation.
* Patients who were extubated at Day 0.
* Patients without any operation or anesthetic complication.
* Patients who speak French.
* Patients without TNC at Day 1.
* Patients who had completed the questionnaires before operation.

Exclusion Criteria:

* Age \< 18 years old.
* Delirium at Day 1.
* Central nervous system pathology or psychiatric pathology known and treated.
* Concomitant use of neuropsychiatric treatment before surgery that interferes with sleep.
* Clinical condition alteration before polysomnography exam.
* Continue sedation required before Day 3 polysomnography exam.
* Agitation or clinical alteration that did not allow Day 3 polysomnography exam.
THE EFFECTS OF DIRECT AND INDIRECT LARYNGOSCOPY ON CORMACK-LEHANE AND POGO SCORES

Direct laryngoscopy (DL) is a conventional and highly difficult method that is used in endotracheal intubation (ETI) training. Today, the usage of video-laryngoscopes (VLs) to teach airway management to inexperienced healthcare personnel is a prevalent practice. In ETI training, it is recommended to train students on simulators before allowing them direct access to patients.


Eligibility Criteria:
Inclusion Criteria:

* Students who were informed,
* whose informed consent was received were invited to participate in the study

Exclusion Criteria:

* Students who were experienced in laryngoscopy,
* those who had received relevant training,
* those who had watched videos on the subject,
* those who refused to participate were excluded.