cyrilzakka/clinical-trials huggingface dataset:
Modified Atkins Diet Versus Topiramate In Children With Epileptic Spasms Refractory To Hormonal Treatment: A Randomized Open-Label Study

This study has been planned to compare the efficacy and tolerability of topiramate, a commonly used second line agent, with modified Atkins diet in children with epileptic spasms refractory to hormonal treatment, in a randomized open label study.

Infantile epileptic spasms syndrome, formerly known as West syndrome is a severe and difficult to treat epilepsy syndrome in infants and young children. The first-line options of this condition include hormonal therapy, i.e., adrenocorticotropic hormone (ACTH) or oral corticosteroids, and/or vigabatrin. These are effective in 45%-55% of the patients. These are however associated with significant side effects, and high relapse rates. Newer drugs such as topiramate, zonisamide, and levetiracetam have also been evaluated; but there have been no randomized trials to evaluate the efficacy of these agents. Topiramate is one of the most commonly used second line agents used for the treatment of epileptic spasms.

The ketogenic diet (KD), a high-fat, low-carbohydrate, adequate-protein diet is an established, effective non-pharmacologic treatment for children with intractable epilepsy. Despite being highly efficacious, ketogenic diet has practical constraints in implementation leading to need for alternative approaches. The modified Atkins diet is a less restrictive variation of the ketogenic diet. This diet is more palatable and acceptable in comparison to ketogenic diet. The modified Atkins diet has shown to be effective in children with epileptic spasms refractory to first line treatment in a recent randomized controlled trial, comparing add-on diet versus continuing the on-going anti-seizure medications alone. At the end of 4 weeks, 11 children in the diet group were spasm free compared with none in the control group (P ≤ .001).

This study has been planned to compare the efficacy and tolerability of topiramate, a commonly used second line agent, with modified Atkins diet in children with epileptic spasms refractory to hormonal treatment, in a randomized open label study. The results will guide clinicians as to the best options in children with epileptic spasms refractory to hormonal treatment.

Eligibility Criteria:
Inclusion Criteria:

1) Age: 9 months to 3 years 2) Diagnosis of infantile epileptic spasms syndrome as per the ILAE 2022 diagnostic criteria 3) Failure of hormonal therapy, i.e. oral prednisolone or ACTH

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Exclusion Criteria:

1) Known or suspected inborn error of metabolism 2) Prior use of the ketogenic or modified Atkins diet or Topiramate 3) Systemic illness- chronic hepatic, renal or pulmonary disease 4) Diagnosed renal stones

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The Effect of Combining Aprepitant With Ondansetron in High-risk Patients for Postoperative Nausea and Vomiting

PONV (Postoperative nausea and vomiting) is one of most common complications after general anesthesia. Female sex, history of PONV, motion sickness, nonsmoker status, use of volatile agents, duration of anesthesia, opioid administration and laparoscopic surgery are known as risk factors for developing PONV. In consequence, patients undergoing laparoscopic gynecologic surgery are at high risk for developing PONV. Most of these patients use fentanyl based IV-PCA. And it also causes PONV.

So, we should prevent PONV in these patients by using multimodal or combination therapy.

Aprepitant is a NK1 receptor antagonist.And it is used to prevent chemotherapy induced nausea and vomiting. Many studies using aprepitant to prevent PONV are in progress.

In this study, we investigate the effect of combining aprepitant with ondansetron in high-risk patients for PONV.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing laparoscopic gynecologic surgery.
* Patient who takes fentanyl based IV PCA
* ASA class I-II

Exclusion Criteria:

* allergy to aprepitant
* take another antiemetics before surgery
* decreased liver function
* psychological disease
* who cannot speak Korean
* take medicines that interacts with emend who do not agree to the study
Use of N-Butyl Cyanoacrylate in Transarterial Emergency Embolization

NBCA is a synthetic biodegradable cyanoacrylate basis glue, modified by the addition of a monomer with adhesive, hemostatic, and antiseptic properties.

Its use requires a steep learning curve to control emulsification of the NBCA/lipiodol mixture, and injection, to avoid non-target embolization.

The aim of this retrospective monocentric study was to evaluate safety and efficacy of use of NBCA as embolic agent in emergency setting.


Eligibility Criteria:
Inclusion Criteria:

* All patients referred to our hospital and treated by TAE with NBCA, based on clinical decisions in emergency and CT scan.

Exclusion Criteria:

* Patients lost for follow-up, patients without preoperative CT.
Nasopharyngeal Versus Laryngeal Mask Airway in Anaesthesia for Bilateral Blepharoplasty

General anaesthesia demands securing patient's airway either with endotracheal tube or laryngeal mask (LMA); however, both carry the disadvantage of postoperative soar throat. Nasopharyngeal airway (NPA) can be an alternative without the risk of postoperative soar throat.6 The primary end point of our study is to assess the incidence of soar throat with the use of NPA compared to LMA in patients receiving general anaesthesia during blepharoplasty.

After approval of medical ethical committee at Ain-Shams University and obtaining written informed consent, 148 adult ASA II-III patients aged between 40 and 60 years old admitted to Ain-Shams university hospitals for blepharoplasty will be enrolled in this study.

Patients will then be randomly and evenly divided into two equal groups (74 patients each) using computer-generated list:

Group N: Patients' nasal mucosa will be anaesthetized and vasoconstricted. K-Y gel will be applied to the tip of nasopharyngeal airway (NPA) of appropriate size. The NPA will then be advanced into the dominant nostril along the septum horizontally.

Group L: K-Y gel will be applied to the tip of the laryngeal mask (LMA) of appropriate size. The LMA will be introduced along the hard palate towards the hypopharynx until resistance is felt.

Anaesthesia will be maintained by sevoflurane 3-4% and propofol infusion 0.5-1 mg.kg-1.hr-1.All patients will receive local infiltration anaesthesia given by the surgeon.

At the conclusion of surgery, sevoflurane and propofol infusion will be discontinued and patients will inhale 100% O2 till spontaneous recovery.

Recovery time will be recorded (defined as the time from discontinuation of anaesthetic drugs till response to verbal command).

Incidence of postoperative soar throat, unsteadiness, nausea and vomiting will be recorded as well as patient and surgeon satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* consented patients, age: 40-60 years old, ASA II-III

Exclusion Criteria:

1. Uncontrolled hypertension (systolic blood pressure \> 160 mmHg) or ischaemic heart disease.
2. Pre-existing coagulation defects or anticoagulation medication.
3. Renal impairment.
4. Recent upper respiratory tract infections, asthma, chronic obstructive pulmonary disease, and smoking.
5. History of obstructive sleep apnea.
6. Chronic drug or alcohol abuse.
7. Morbid obesity; BMI \>40 or BMI \>35 and experiencing obesity-related health conditions, such as high blood pressure or diabetes.
8. Allergy to any of the drugs used in the study.
Pharmacokinetic Study of Synera in Healthy Volunteers

This study will measure the amount of lidocaine and tetracaine in the blood after 2-, 4-, and 12-hour application of 4 Synera patches and a 4 hour application of 4 patches without heat.

The purpose of this study was to evaluate the pharmacokinetic profiles of lidocaine and tetracaine after 2-, 4-, and 12-hour application of 4 Synera® patches and a 4-hour application of 4 lidocaine/tetracaine patches without heat in healthy adult subjects and to monitor the frequency and nature of adverse events. In addition to determining the pharmacokinetics for a one-time application of 4 Synera® patches, steady-state pharmacokinetics were modeled and residual patch concentrations of lidocaine and tetracaine were determined.

Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age
* be a nonsmoker
* have a body mass index (BMI) ≥ 18.5 and \< 30.0

Exclusion Criteria:

* known or suspected hypersensitivity, allergies, or other contraindications to any compound present in the study drug, including lidocaine, tetracaine, or other local anesthetics.
* have a defect, injury or a dermatological disease or condition in the skin area where the study drug was to be applied.
* have a history or current evidence of any hepatic impairment.
* have failed the urine drug screen.
* have used or been administered a local or systemic anesthetic, including over-the-counter products, within the past 14 days.
* have donated blood or plasma within the past 30 days.
* have participated in a clinical research study within the past 30 days.
* are pregnant, breastfeeding, or was a female of childbearing potential and not practicing adequate birth control
Phase I/II Study of High-Dose Calcitriol Plus Temodar for Patients With Metastatic Melanoma

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Calcitriol may help temozolomide kill more tumor cells by making them more sensitive to the drug. Calcitriol may also stop the growth of melanoma by blocking blood flow to the tumor.

PURPOSE: This phase I/II trial is studying the best dose of calcitriol, the side effects of calcitriol when given together with temozolomide, and to see how well they work in treating patients with metastatic stage IV melanoma.

\* Phase I: Patients receive oral calcitriol on days 1 and 15 and oral temozolomide on days 2-8 and 16-22. Treatment repeats every 28 days for 2 courses in the absence of unacceptable toxicity. Responding patients continue therapy for up to 6 courses in the absence of unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

* Phase II: Patients receive temozolomide and calcitriol at the MTD as in phase I.

After completion of study treatment, patients are followed every 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignant melanoma

  * Any primary tumor site
* Stage IV disease

  * CNS metastases allowed
* Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension as ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* Must have had at least 1 prior systemic therapy
* Negative pregnancy test
* Fertile patients must use effective contraception

  * Patients with no prior systemic therapy are eligible provided they are not candidates for high-dose interleukin-2
* Recovered from all toxic effects of prior therapy
* More than 4 weeks since prior and no concurrent radiotherapy, chemotherapy, or immunotherapy
* More than 4 weeks since prior and no concurrent radiotherapy, chemotherapy, or immunotherapy
* Fertile patients must use effective contraception

Exclusion Criteria:

* Life expectancy less than 4 months
* known HIV positivity
* evidence of active infection requiring antibiotic therapy
* other malignancy within the past 5 years except surgically resected basal cell or squamous cell skin cancer
* significant medical disease which, in the opinion of the investigator, may interfere with study completion
* pregnant or nursing
* Negative pregnancy test
* prior temozolomide or dacarbazine
* investigational agent within 4 weeks prior to study entry
* concurrent magnesium-containing antacids, digitalis, bile-resin binding drugs, or calcium supplements
In-hospital Outcomes of Older Patients With Gastric Cancer and Their Risk Factors

The investigators plan to analyze the data of patients with gastric cancer (GC) consecutively hospitalized in Ruijin Hospital, a large tertiary center in China, comprehensively describe the characteristics of GC patients ≥65 years, and assesse their in-hospital outcomes regarding duration, fee, and death. Factors associated with the in-hospital outcomes will be further comprehensively explored.


Eligibility Criteria:
Inclusion Criteria:

* Older gastric cancer (GC) patients
* With primary malignancies of the stomach (International Classification of Diseases for Oncology, Third Edition \[ICD-O-3\] topology code: C16)
* ≥65 years

Exclusion Criteria:

* With benign, premalignant, or in situ tumors
* With cancers originating from non-stomach sites
Study to Determine if Pre- and Post- Operative TAP Catheters With Ropivacaine Versus Placebo Affects Anesthetic, Narcotic Dosing, and Pain Scores

A randomized controlled trial to determine if pre- and post- operative regional pain control (transversus abdominis plane block) with ropivacaine versus placebo leads to lower anesthetic and narcotic dosing, and alters pain scores.

This study plans to learn more about regional anesthesia and pain control during abdominal surgery. The study will gather data about the effectiveness of continuous catheter infusion of local anesthetic after an abdominal operation. Outcomes include pain scores, IV pain medicine requirements, and delirium.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=50 years.
* Subjects will be undergoing an elective intra-abdominal or abdominal wall operation, including pelvic operations. Surgery specialties included are general surgery, surgical oncology, urology, gynecology, plastic surgery.

Exclusion Criteria:

* Subjects with a history of dementia or aphasia, as visual analog scale and confusion assessment will be unreliable.
* Patients with an epidural or spinal catheter block.
* Patients who do not speak English so that a language barrier is not confused with VAS scoring or confusion.
* Patients who are abusing alcohol defined by a high AUDIT score (\>8) will be excluded.
* History of bipolar disorder or a psychotic disorder (such as a psychotic major depression, schizophrenia, schizoaffective disorder, or psychosis in Alzheimer's disease or other dementia).
* Patients with a documented allergy to ropivacaine or other sodium channel blockers.
Workplace Based Physiotherapy of Elderly-care Workers With Non-specific Neck Pain.

The overall objective of this study is to determine the efficacy of a physical therapy intervention based on manual therapy, therapeutic exercise and application of electrotherapy in healthcare workers with non-specific neck pain.

The subjects included in the sample will be evaluated according to the aforementioned parameters by researchers trained and assigned for this purpose.

The data collection of the different variables will be performed before and after the completion of the program designed for the study. The physiotherapy intervention for the experimental group will have a duration of 10 sessions, twice a week.

Eligibility Criteria:
IInclusion Criteria:

* Age range between 18-60 years.
* Cervical pain of non-specific origin or Cervicalgia type I and II according to the Quebec - Task Force on Spinal Disorders.
* Be willing to participate in the study and sign the informed consent form.
* Have at least one year of seniority in the company exercising the current professional activity within the team of socio-health personnel.

Exclusion Criteria:

* Cervicalgia with neurological involvement or caused by pathologies such as: inflammatory disease, neurological disease, rheumatic disease, severe osteoporosis, fracture, dislocation, vertebro-basilar insufficiency, neoplasia or infection.
* Spine surgery.
* Present metallic implants at the spinal column level.
* Have received physiotherapy or alternative treatment in the last 6 months before starting the study.
* To present any type of inconvenience to the application of electrotherapy (score ≥45 points in EAPP).
Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients

Autologous epidermal cell suspension grafting is an effective method of surgical treatment in vitiligo, which is suitable for treating larger areas with better cosmetic results as compared to other grafting methods. The ReCell Autologous Cell Harvesting Device (Avita Medical Europe Limited, Cambridge, UK) is an autologous cell harvesting device which, compared to other forms of autologous epidermal cell suspension grafting, is easier in use showing similar results. Furthermore, the ReCell device needs no laboratory facilities. Therefore, it is promising for patients with large vitiligo and piebaldism lesions.

Objectives: Primary: to asses the efficacy and safety of autologous epidermal cell suspension grafting with the ReCell device after CO2 laser abrasion compared to CO2 laser abrasion alone and no treatment, in patients with piebaldism and stable vitiligo. Secondary: to assess the practical aspects and patients satisfaction of autologous epidermal cell suspension grafting with the ReCell device.

Study design: Prospective observer blinded randomized controlled pilot study. Study population: 10 patients ≥ 18 years with stable segmental vitiligo or piebaldism who are under treatment at the Netherlands Institute for Pigment Disorders (NIPD) at the Academic Medical Centre University of Amsterdam.

Methods: Three depigmented regions on the trunk or proximal extremities will be randomly allocated to; CO2 laser abrasion + ReCell autologous cell suspension grafting, or CO2 laser abrasion, or no treatment. After the transplantation, UV-treatment according to the standard treatment protocol of the NIPD will be started on all sites and continued for 3 months. Three and six months after grafting, the percentage of repigmentation of the lesions will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* patient with piebaldism
* Patients with segmental vitiligo,stable since 12 months without systemic therapy or topical therapy as defined by the absence of new lesions and/or enlargement of existing lesions
* with at least three depigmented skin lesions on the proximal extremities or trunk larger than 3x3 cm or one lesion of at least 9x3 cm
* Age \>18
* willing and able to give written informed consent

Exclusion Criteria:

* UV therapy or systemic immunosuppressive treatment during the last 12 months
* Local treatment of vitiligo during the last 12 months
* Vitiligo lesions with follicular or non-follicular repigmentation
* Skin type I
* Recurrent HSV skin infections
* Hypertrophic scars
* Keloid
* Cardial insufficiency
* Patients with a history of hypersensitivity to (UVB or UVA) light and/or allergy to local anesthesia.
* Patients who are pregnant or breast-feeding
* Patients not competent to understand the procedures involved
* Patients with atypical nevi
* Patients with a personal history of melanoma or non-melanoma skin cancer
Hypotension in the Weaning From Vasopressor Drugs

Although there is consensus in the literature on hemodynamic management of septic shock in the resuscitation phase, the best way to conduct the weaning of vasopressor drugs in the stabilization phase remains open. The present study aims to study the incidence of hypotension in the weaning phase of vasopressor drugs- norepinephrine and vasopressin.

A randomized, open-case clinical trial with 2 arms will be conducted: initial suspension of norepinephrine (norepinephrine group) versus initial vasopressin (vasopressin group).

The selection of patients who will participate in the study will be for convenience. The randomization of the patients will be done by opaque envelopes 1:1, grouped into blocks, generated by random numbers.

The study will be carried out in the intensive care unit of a tertiary hospital in Southern Brazil, taking into account the clinical and surgical patients. In the intensive care unit, after randomization, patients will be identified by posters, attached to the bed. The titration of vasoactive drugs will be criterion of the assistant team.

Eligibility Criteria:
Inclusion Criteria:

* Patients with septic shock, according to the definitions of SEPSIS - 3: septic and hypotensive patients, demanding use of vasoactive drug and lactate greater than 2 mmol/L (18 mg/dL).
* Patients admitted to the intensive care unit.
* Patients in need of associated use of norepinephrine and vasopressin.

Exclusion Criteria:

* Patients in whom discontinuation of norepinephrine or vasopressin has been given by decision of the assistant team, from a perspective of prioritizing palliative care.
* Patients using a combination of a third drug, with the effect of predominantly vasopressor - adrenaline.
Prognostic Biomarkers in CO Poisoning

Mitochondrial and oxidative stress participate in the pathogenic mechanisms of carbon monoxide (CO)-induced toxicity. Thus, serum indicators of mitochondrial and oxidative stress could be useful for predicting neurocognitive prognosis of post-CO poisoning. This prospective observational study of consecutive patients requiring hyperbaric oxygen therapy (HBO2) for acute CO poisoning measured serum biomarkers of mitochondrial (growth differentiation factor 15 \[GDF15\]; fibroblast growth factor 21 \[FGF21\]) and oxidative (8-Oxo-2'-deoxyguanosine \[8-OHdG\] and malondialdehyde \[MDA\]) stresses at arrival at the emergency department (0 h), and at 24 h and 7 days after HBO2 completion. We evaluated neurocognitive outcomes using the Global Deterioration Scale (GDS; favorable \[1-3 points\] or poor \[4-7 points\] outcomes).

Mitochondrial and oxidative stress participate in the pathogenic mechanisms of carbon monoxide (CO)-induced toxicity. Thus, serum indicators of mitochondrial and oxidative stress could be useful for predicting neurocognitive prognosis of post-CO poisoning.

This prospective observational study of consecutive patients requiring hyperbaric oxygen therapy (HBO2) for acute CO poisoning measured serum biomarkers of mitochondrial (growth differentiation factor 15 \[GDF15\]; fibroblast growth factor 21 \[FGF21\]) and oxidative (8-Oxo-2'-deoxyguanosine \[8-OHdG\] and malondialdehyde \[MDA\]) stresses at arrival at the emergency department (0 h), and at 24 h and 7 days after HBO2 completion. We evaluated neurocognitive outcomes using the Global Deterioration Scale (GDS; favorable \[1-3 points\] or poor \[4-7 points\] outcomes).

Levels of serum mitochondrial (GDF15 and FGF21) and oxidative stress (8-OHdG and MDA) biomarkers pre- and post-HBO2 were compared, to assess whether HBO2 reduced stress. In addition, we evaluated whether the blood test results correlated with the patient's neurocognitive prognosis at 1 month.

Eligibility Criteria:
Inclusion Criteria:

* CO poisoned patients

Exclusion Criteria:

1. age \< 19 years
2. a history of metabolic diseases
3. co-ingestion of drugs and alcohol, which may affect the biomarkers
4. discharge from the ED or transfer to another hospital
5. refusal to undergo HBO2
6. refusal to enroll in this study
7. lack of follow-up for assessing neurocognitive outcomes.