cyrilzakka/clinical-trials huggingface dataset:
The Best Dose of Esketamine for Day Surgery of Pediatric Circumcision Pediatric Circumcision

In recent years, daytime operation has been developed gradually in China. Circumcision in children is a common type of daytime operation. The nature of the operation and the object of the operation determine that the anesthetic drugs used should induce fast, wake up quickly and recover in a high quality.

Esketamine is an S-enantiomer of ketamine, which is newly marketed in China. Compared with ketamine, it has stronger effect on NMDA receptor, and its sedative effect is about twice as high. The occurrence frequency of respiratory depression and hypotension is lower than that of other anesthetics and analgesics, which can provide good analgesic and sedative effect for surgical anesthesia.

In clinical practice, ketamine combined with sevoflurane has been widely used in children's microsurgery, but there has been no report on Esketamine combined with sevoflurane anesthesia.

In order to find out the best combined dose, this paper compares the single administration of three different doses of esketamine combined with sevoflurane anesthesia in the circumcision of children.

To investigate the optimal dose of esketamine combined with sevoflurane for pediatric circumcision. Methods children who underwent day surgery of pediatric circumcision were randomly divided into 3 groups according to the random number table method:0.5mg/kg esketamine group (Group A), 0.75mg/kg esketamine group (Group B) and 1.0mg/kg of esketamine group (Group C), with 30 people in each group. mask inhalation of sevoflurane anesthesia, each group was given a single intravenous dose of the corresponding esketamine. Heart rate (HR), mean arterial pressure (MAP), pulse oxygen saturation (SpO2) and respiratory rate (RR) were recorded at room entry (T0), intravenous ketamine administration (T1), operation initiation (T2), intraoperative central ligation (T3) and operation completion (T4).The number and total amount of ketamine added intraoperatively were recorded. Duration of operation, time to open eyes and time to answer were recorded. The Eastern Ontario Children's Hospital pain Score (CHEOPS score) and the modified Bieri pain score were recorded when awake, 2 hours and 6 hours postoperatie. MOAA/S score was recorded at 15, 30 and 60min after surgery. Intraoperative and post-operative adverse reactions were recorded, including hypersensitivity, agitation, nausea and vomiting, dizziness, diplopia, etc.

Eligibility Criteria:
Inclusion Criteria:

* phimosis

Exclusion Criteria:

* cardiopathy
* asthma
* dysgnosia
* surdimutism
* hepatopathy or nephropathy
Comparison of Esophageal and Tracheal Temperature in the Patients Using Breathing Circuit With Heated Wire Humidifier

When using a breathing circuit with heated wire humidifier, investigators will check if the temperature measured by the thermometer of the endotracheal tube is more than 0.25 degrees apart from the temperature measured by the esophageal thermometer. Through this, in the case of patients who need to use a breathing circuit with heated wire humidifier, investigators will find out whether it is appropriate to use an esophageal or endotracheal thermometer.

It is known that hypothermia occurs in approximately 50-90% of surgical patients under general anesthesia, and intraoperative hypothermia can lead to various complications such as wound infection, coagulation disorders, increased frequency of cardiac complications, ventricular fibrillation, prolonged effects of anesthesia drugs, shivering, and weakened immune function. Additionally, inadequate maintenance of temperature during surgery can result in delayed discharge from the recovery room, delayed recovery, and extended hospitalization. Therefore, accurate measurement of body temperature and active temperature management are crucial during surgery. Although there are various sites for temperature measurement, measuring the core body temperature in well-perfused deep tissues, which have a higher temperature and greater reliability than other sites, is essential. While esophageal temperature measurement is commonly used in patients undergoing general anesthesia, there may be cases where esophageal temperature probe cannot be inserted due to bleeding tendencies or lesions in the esophagus. In such cases, measuring temperature through the tympanic membrane or an endotracheal device becomes possible, but using a heated humidification breathing circuit for patient warming may affect the endotracheal temperature. Although there are animal study results comparing esophageal temperature and endotracheal temperature, research on the comparison of esophageal and endotracheal temperatures in humans is limited, and there is no study on the comparison of esophageal and endotracheal temperatures when using a heated humidification breathing circuit. The investigators aim to verify whether there is a temperature difference of 0.25 degrees or more between the temperature measured through the endotracheal device and the temperature measured by the esophageal thermometer when using a heated humidification breathing circuit. Through this investigation, they seek to determine which thermometer, either esophageal or endotracheal, is more appropriate to use in patients requiring the use of a heated humidification breathing circuit.

Eligibility Criteria:
Inclusion Criteria:

* males and females between the ages of 20 and 60 and meet the criteria for classification I and II of the American Society of Anesthesiology

Exclusion Criteria:

* Patients with a predisposition for bleeding
* Patients with a history of inability to insert an esophageal thermometer (esophageal varices, esophageal stenosis, esophageal malformation, and anatomical deformation after esophageal surgery)
* pregnant woman
Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease

The purpose of this study is to assess the efficacy of cholestagel to reduce the frequency of soft and liquid stools per day in patients with CD in clinical remission with symptoms of BAM and to assess the improvement in stool consistency and quality of life in these patients and to assess the safety of cholestagel.


Eligibility Criteria:
Inclusion criteria:

* Signed informed consent after adequate explanation of the patient information.
* Male and female patients with CD and 18 to 65 years of age in clinical remission with a Crohns Disease Activity Index (CDAI) score of 150 or less, with symptoms of functional BAM or symptoms of BAM after small bowel resection with a frequency of at least 3 to maximal 15 liquid or soft stools per day.
* Stable medical treatment of CD for a minimal period of 3 months preceding the screening visit, consisting of

  * either continuous oral treatment of aminosalicylate, prednisolone (a maximum 10 mg/day), azathioprine, 6-mercaptopurine, or methotrexate
  * or supporting periodic treatment\* with TNF-alpha AK (Infliximab, Adalimumab, Certolizumab) (for patients on TNF-alpha, dosing with TNF-alpha should coincide with baseline visit)
* Blood serum CRP value of less or equal then 1 mg/dl (10 mg/l).
* BAM assessed with a blood test on a 7α-hydroxy-4-cholesten-3-on excretion of equal or more than 50 ng/ml

Exclusion criteria:

* Allergy or hypersensitivity to any of the components of cholestagel or placebo as identified from the medical history
* Participation at another clinical trial within a period of 4 weeks before the screening visit
* Presence of any addiction, alcohol abuse or specific disease that would not allow the patient to understand the essence and requirements and potential consequences of the participation to the clinical trial
* Signs suggestive of the patient being unable to follow the visit schedule as required (for example for professional obligations)
* Treatment with cyclosporine, or tacrolimus, 3 month or less before screening
* Oral Treatment with antibiotics 3 weeks or less before screening
* Topical treatment with steroid- or mesalazine-containing applications 3 weeks or less before screening
* Treatment with bile acid bile acid binding agent (e.g. Cholestayramine)6 weeks or less before screening
* Infectious diseases (HIV, hep B, hep C, tuberculosis, listeriosis, positive clostridium-difficile-toxin- proof in faeces)
* Current presence of intra-abdominal abscess or Fistula
* Cholestatic liver disease, bowel or biliary obstruction
* Dysphagia or swallowing disorders
* Known malignancy or history of malignancy
* Having undergone intestinal surgery within 6 months from screening
* Status after intestinal surgery with more then 100cm of resected bowel.
* Short bowel syndrome
* Planned -gastrostomy, ileostomy or colostomy.
* Pregnancy and lactation
Online Brief CBT Intervention for Women With PCOS

Primary Objective:

-To study if an online individual brief CBT (group A) intervention is effective for psychological distress (anxiety and depression) compared to a CAU group in patients with PCOS at 3 and 6 months relative to baseline.

Secondary Objective(s):

1. To study if an online group based brief CBT (group B) is more effective for anxiety and depression compared to CAU in patients with PCOS at 3 and 6 months relative to baseline.
2. To determine if an online individual brief CBT (group A) is effective for improvements in QoL, coping strategies, body image and sleep quality compared to CAU in patients with PCOS at 3 and 6 months relative to baseline.
3. To determine if an group based brief CBT (group B) is more effective for improvements in QoL, coping strategies, body image and sleep quality compared to CAU in patients with PCOS at 3 and 6 months relative to baseline.
4. If A and B are effective compared to CAU, we will compare online individual brief CBT (group A) to online group based brief CBT (group B) for anxiety and depression, QoL, coping strategies, body image and sleep quality compared to in patients with PCOS at 3 and 6 months relative to baseline.

The online brief CBT intervention is designed to address three problems that have often been reported in women with PCOS. Therefore, the program contains three themes: Psychoeducation about PCOS; traditional CBT and problem-solving therapy.

Participants are randomized into one of three groups:

1. individual treatment (A)
2. group treatment (B)
3. care as usual (CAU)

Treatment A and B include 5 sessions divided over a period of 3 months:

Week 1: Session 1 +homework assignments Week 3: Session 2 +homework assignments Week 5: Session 3 +homework assignments Week 8: Session 4 +homework assignments Week 12: Session 5 +homework assignments

The CAU group receives standard treatment for depressive symptoms from their general practitioner (GP).

Eligibility Criteria:
Inclusion Criteria:

* women with a confirmed diagnosis of PCOS based on the Rotterdam criteria
* body Mass Index (BMI) ≥18.5 kg/m2
* aged 18-55 years.
* mild depressive symptoms or anxiety scores based on the Hospital Anxiety and Depression Scale (HADS) and/or a negative body image based on the Body Cathexis Scale (BCS).

Exclusion Criteria:

* pregnancy
* current treatment for clinical depression, anxiety disorders or eating disorders
* suicidality (indicated by a score \>2 on the Beck Depression Inventory II suicide item)
* having an endocrine disease (diabetes mellitus, thyroid function disorders, Cushing's disease, adrenal tumors, and congenital adrenal hyperplasia)
* inability to speak, read or write Dutch.
Impact of Vaccination on Th2 Immunity in Infancy

The purpose of this study is to assess the responses in the immune system of infants after they receive the vaccine against diphtheria, tetanus, and pertussis (DTaP). The investigators will do this by studying the immune cells and allergy responses in the blood prior to and after receipt of the third DTaP vaccine.

This is a single-site study of infants who are scheduled to receive their third series (\~6 month) vaccinations, as routine care, to investigate whether the diphtheria, tetanus, and pertussis (DTaP) vaccination has an effect on specific immunoglobulin E (IgE) levels to milk, egg, or peanut. Infants will be assigned to one of two groups depending on the infant's sensitization to milk, egg, and peanut.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from parent/guardian
* General good health without other known need for blood draws that would conflict with the study volume requirements
* Aged 5 months - 7 months, any race/ethnicity, any gender
* Subjects must not have yet received their third DTaP vaccination, which typically is given at 6 months of age. Subjects must have previously received two doses of the DTaP vaccination, at ages 2 months and 4 months
* Willingness to return for follow-up testing as defined in the protocol and consent if screening tests indicate eligibility
* Group 1 participants must have all of the following:

  * A negative skin prick test to egg, milk, and peanut
  * A negative IgE to egg, milk, and peanut
* Group 2 participants must have all of the following:

  * A positive family history of allergic disease
  * Atopic Dermatitis not requiring prescription medication
  * A positive IgE to milk, egg, and/or peanut

If Group 1 enrollment is completed first, participants must have all of the following to be enrolled in Group 2:

* A family history of atopy
* Atopic dermatitis not requiring prescription medication

If Group 2 enrollment is completed first, participants must have all of the following to be enrolled in Group 1:

-No personal or family history of atopic disease

Exclusion Criteria:

* History of anemia requiring any treatment
* Previous allergic reaction to any food, defined as itching, rash, hives, swelling, vomiting, diarrhea, sneezing, rhinorrhea, wheezing, breathing difficulty, or passing out immediately after food ingestion.
* Evidence of non-IgE-mediated reaction to milk or soy (i.e. milk/soy protein intolerance) or evidence of food protein induced enterocolitis syndrome (FPIES)
* Severe atopic dermatitis (liberally defined as requiring prescription medication)
* Unable to obtain serum sample for determination of egg, milk and peanut IgE levels
* Use of short-acting anti-histamines (diphenhydramine, etc.) more than one time within 3 days of skin testing or on the day of skin testing
* Any history of intravenous or oral steroid medication
* Known underlying immune defect/deficiency or bleeding disorder
Biomarkers in Concussion

This will be an observational study measuring serum Neurofilament Light Chain concentrations and associated symptoms, with a control branch, and a post-concussion branch.


Eligibility Criteria:
Inclusion Criteria:

Over 12 years of age Athletes participating on a sports team willing to participate; undergo blood draws either weekly or every two weeks, depending on arm of study.

Exclusion criteria:

Existing active neurodegenerative disorder (ie severe TBI) Active peripheral nerve disorder (ie diabetic neuropathy)
Comparison of Intraoperative HR and RR Acquired Via ATLASense Raphael PolyMonitor and Standard Intraoperative Monitors

The aim of this observational comparison study is to compare the HR and respiratory RR of intraoperative surgical patients simultaneously recorded by standard intraoperative monitors and the ATLASense RAPHAEL PolyMonitor. A second aim is to determine the extent of data loss and data gap duration, and validate the PolyMonitor alert system for tachycardia and bradycardia. Additional parameters of non-invasive blood pressure (NIBP) and body temperature will also be compared between the PolyMonitor and standard intraoperative monitors. Finally, this study will provide insight into the logistics of intraoperative use of the PolyMonitor.

The ATLASense Raphael PolyMonitor will be placed on the patient's left chest mid sternal line in the operating room. Traditional physiologic monitors described above will also be placed on the patient in the operating room. Data will be collected via the ATLASense system and through the traditional operating room monitors, and this data will be time matched through synchronization of the monitors post hoc. The time matched data pairs will undergo statistical analysis post hoc. It is anticipated that this study will validate the intraoperative HR and RR measured through the ATLASense Raphael PolyMonitor, providing adequate data points for statistical analysis with 95% limits of agreement, bias, and data loss/gaps. Success is also the logistical lessons learned for using this monitor in the intraoperative setting.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Adult males or females (above the age of 18)
* Scheduled to undergo general anesthesia during elective surgery

Exclusion Criteria:

* Pregnant adult female
* Thoracic surgery
* Left lateral decubitus positioning required during procedure
* Surgery involving the left flank, or requiring surgical field involving the left flank
* Surgery involving the left chest, or requiring surgical field involving the left chest
* Allergy to adhesives
* Open wound, rash, or sore involving the left chest
* Presence of cardiac defibrillator, or pacemaker
ANG1005 in Patients With Recurrent High-Grade Glioma

This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in patients with high-grade glioma. Another purpose of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of ANG1005 in patients.

See above.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old
2. GBM and GBM variants, WHO Grade III anaplastic glioma diagnosis confirmed
3. Radiologically confirmed recurrent and bi-dimensionally measurable disease per Response Assessment in Neuro-Oncology (RANO) criteria
4. Neurologically stable
5. For bevacizumab-refractory patients, radiologic demonstration of tumor progression during bevacizumab therapy
6. Karnofsky performance status (KPS) ≥ 80
7. Expected survival of at least 3 months

Exclusion Criteria:

1. More than three relapses
2. Previous ANG1005/GRN1005 treatment
3. Radiotherapy within 3 months.
4. Therapy with bevacizumab within 4 weeks prior to Day 1 of treatment for recurrent WHO grade III anaplastic glioma patients (Arm 3)
5. Evidence of significant intracranial hemorrhage
6. Previous taxane treatment
7. Prior therapy with bevacizumab for bevacizumab-naïve patients (Arm 1)
8. NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 Grade ≥ 2 neuropathy
9. Inadequate bone marrow reserve
10. Any evidence of severe or uncontrolled diseases
11. Participants with the presence of an infection including abscess or fistulae, or known infection with hepatitis C or B or HIV
12. Known severe hypersensitivity or allergy to paclitaxel or any of its components
Effects of Virtual Reality (VR) Based Distraction and Relaxation Therapy on Moderate and Severe Pain

This is a prospective, single-arm, open, single-center clinical study. This study is a pilot study to explore the use of VR based distraction and relaxation therapy as an adjunctive analgesic method for Chinese patients with moderate to severe pain. After screening, patients with moderate to severe pain who meet the study inclusion criteria receive VR therapy for 15 minutes to evaluate the effectiveness and safety of VR therapy.


Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥18 years old.
* Average pain intensity≥4 on a 0-10 numerical rating scale (NRS) in the past 24 hours.
* Be able to communicate in Chinese.
* Be able to read and write Chinese.
* Willing to comply with study procedures and restrictions.
* Willing and able to sign informed consent.

Exclusion Criteria:

* Shingles on the eyes, ears, head, face, or hands.
* Trigeminal neuralgia.
* Severe vision impairment. (Patients with clear vision wearing glasses or contact lenses are allowed)
* Severe hearing impairment.
* Disease or medical condition predisposing to nausea or dizziness, such as insufficient blood supply to the brain, vestibular dysfunction, cholecystitis, etc.
* History of severe motion sickness.
* Injury to eyes, ears, face, or neck that impedes comfortable use of virtual reality.
* Injury or dysfunction of hands or upper limbs that impedes comfortable use of virtual reality.
* Diagnosis of cognitive impairment, epilepsy, dementia, migraines or other neurological diseases that may prevent the use of virtual reality.
* History of mental illness, including depression, generalized anxiety disorder, schizophrenia, etc.
* Females currently pregnant.
* Current or completion of participation within 4 weeks before screening in any interventional clinical study
* Patients whom the investigator considers not suitable to participate in this study.
Volatile Anesthetic Protection of Renal Transplants 2

To compare the effect of a sevoflurane based anesthesia versus a propofol based anesthesia on the incidence of DGF in recipients of kidneys of donation after circulatory death (DCD) and donation after brain death (DBD) donors

Objective:

To compare the effect of a sevoflurane based anaesthesia versus a propofol based anaesthesia on the incidence of delayed graft function in recipients of DCD and DBD donor kidneys.

Study design:

Prospective randomized controlled European multicentre clinical trial with two parallel groups

Study population:

Patients ≥18 years scheduled for kidney transplantation with a kidney from a DBD or DCD donor

Intervention:

Patients will be included and randomised to one of the following groups:

Group 1 PROP (control): Propofol: a propofol-remifentanil based anaesthesia. Group 2 SEVO (intervention): Sevoflurane: a sevoflurane-remifentanil based anaesthesia.

Main study parameters:

DGF defined as need of dialysis the first week after transplantation excluding one time dialysis for hyperkalemia Acute rejection episodes within the first year after transplantation Graft and patient survival GFR at 3 and 12 months PNF defined as a permanent lack of function of the allograft Length of hospital stay Postoperative complications of all kind kidney biomarkers (urine/plasma) mechanisms of protection/immunomodulation with anestheticanaesthetic agents

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Written informed consent

Exclusion Criteria:

* high immunological risk as determined bij local practice
* Patients of the ABO-incompatible program
Comparison of Two Different Medications Used to Treat Elevated Intracranial Pressure

The overall purpose of this study is to compare the effects of mannitol and hypertonic saline on patients with increased intracranial pressure. The hypothesis being tested is that hypertonic saline is more effective in controlling increased intracranial pressure than mannitol.


Eligibility Criteria:
Inclusion Criteria:

* Documented SAH (by computed tomography or lumbar puncture), ICH, TBI or brain tumor
* Patient greater than or equal to 18 years of age
* ICP monitor in place
* ICP greater than 20mmHg, not related to a transient noxious stimulus and not responding to standard measures for controlling ICP (ventricular drainage, elevation of head of the bed and optimizing PaCO2)
* Patient or patient's legally authorized representative has provided written informed consent

Exclusion Criteria:

* Patient less than 18 years of age
* Lack of ICP monitoring
* Patient received Mannitol prior to placement of ICP monitor
* Baseline serum osmolarity of greater than 310 mOsm/L
* Patient is currently enrolled in another investigational drug or device study
* Congestive heart failure at time of enrollment
* Chronic renal failure on hemodialysis
* Pregnancy