cyrilzakka/clinical-trials huggingface dataset:
Auditory Intraoperative Stimulation Effects on Pain and Agitation at Awakening (AUDIOPAW)

Adenotonsillectomy (AT) is one of the most common pediatric surgical procedures. The management of postoperative pain and agitation after AT is still a controversial issue. Safety considerations limit the use of opioids and non-steroidal anti-inflammatory drugs, leading to inadequate control of the high levels of postoperative pain experienced by AT patients. Along with pain killers, non-pharmacological strategies have remarkable impact on pain management in children. A systematic review and meta-analysis published in The Lancet in 2015 on adult patients suggest that auditory stimulation with music in the perioperative setting, and even when patients are under general anaesthesia, can reduce postoperative pain, anxiety, and analgesia needs. The authors concluded that there is sufficient evidence to implement auditory stimulation in the treatment of all adult surgical patients, regardless of the mode of administration. Up to now, no research has investigated the effects of intraoperative auditory stimulation on pain and agitation upon awakening after AT in the pediatric population. Objective of this study is to determine the effects of intraoperative auditory stimulation on pain and agitation upon awakening after pediatric AT.


Eligibility Criteria:
Inclusion criteria:

* age 2 to 17 years old
* scheduled for adenotonsillectomy
* recent audiometry and tympanometry evaluation (\<1 month)

Exclusion Criteria:

* no informed consent
* other combined surgical procedures
* comorbidities (e.g. congenital anomalies of the head-and-neck, psychomotor delay, autism spectrum disorders)
* American Society of Anesthesiologists (ASA) Classification score \>2
* ongoing chronic pharmacological therapy
* first language not Italian
* environmental noise exceeding limits in the operating room
Efficacy of High Dose Olanzapine for the Treatment of Schizophrenia and Schizoaffective Disorder

The purposes of this study are to assess the efficacy, safety, and side effects among doses approved by the Food and Drug Administration and higher (not FDA approved) doses of olanzapine in patients with schizophrenia or schizoaffective disorder.


Eligibility Criteria:
Inclusion Criteria:

* You must be 18 to 60 years old
* You must have been diagnosed with schizophrenia or schizoaffective disorder
* You must be able to visit the doctor's office 8 times over a 9 week period
* You must agree to participate with all tests and examinations that are required for this study

Exclusion Criteria:

* You are a woman and are pregnant or breastfeeding
* You presently have an acute or unstable medical illness
* You have a history of an allergic reaction to olanzapine
* You are taking medications that are not permitted in this study. Your physician will discuss these with you
* You have taken part in another clinical research trial within the last 30 days or you have received treatment with a drug in the last 30 days that has not received regulatory approval.
Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)

The purpose of this study is to design a prospective randomized clinical trial to explore whether postoperative adjuvant chemotherapy may provide survival benefit for stage II colon cancer patients with high risk factors.Therefore the investigators can provide high level clinical evidence of indications for patients with colon cancer with stage II colon cancer.

The most controversial of adjuvant chemotherapy for colon cancer is whether stage II colon cancer should receive adjuvant chemotherapy or not. Because of the absolute little benefit of adjuvant chemotherapy after curative resection of stage II colon cancer，NCCN and ESMO guidelines do not recommend routine adjuvant chemotherapy for patients with stage II colon cancer unless combined with high risk factors.

Currently，most studies about stage II colon cancer with high risk factors were retrospective. Some suggested that patients with stage II colon cancer can benefit from adjuvant chemotherapy, however, more got the negative conclusions.

The study was designed as a multicenter, prospective, randomized, controlled trial.Patients who agreed to participate in the study would be randomly assigned to a treatment group of adjuvant chemotherapy or observation with 50% chance by a central randomization system determined by the computer program.

After a follow up of at least 3 years, the disease free survival of the two groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. aged 18 to 75 years;
2. pathologically confirmed adenocarcinoma of the colon
3. after curative resection pathological stage was T3-4N0M0;
4. with at least one of the following factors:

   1. T4 staging
   2. lymph nodes number less than 12
   3. poor differentiation (except MSI-H)
   4. LVI or PNI
   5. obstruction or perforation
   6. Elevated preoperative serum CEA
5. ECOG Performance status 0-1
6. no evidence of distant metastases
7. no preoperative chemotherapy or chemoradiation therapy
8. ANC \> 1.5 cells/mm3, HGB \> 10.0 g/dL, PLT \> 100,000/mm3, total bilirubin ≤ 1.5 xULN, AST≤ 3 x ULN, ALT ≤ 3 x ULN.
9. Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.

Exclusion Criteria:

1. combined with other cancer
2. Creatinine level greater than 1.5 times the upper limit of normal.
3. Patients who have received preoperative chemotherapy or chemoradiotherapy.
4. Patients with a history of a prior malignancy within the past 5 years.
5. Women who are pregnant or breast-feeding.
6. patients may not complete the whole schedule of chemotherapy
7. Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
Tooth Wear and Associated Risk Factors

This study compares the associated risk factors between adults with tooth wear and age- and sex-matched controls without tooth wear.

Some people are at greater risk due to their eating and brushing habits. Poor oral health behaviors and malnutrition are the leading causes of tooth surface loss in adults. Fluid consumption trends have changed, and the increased consumption of carbonated drinks coincides with a decline in the consumption of dairy products and increases in the use of packaged products. Frequent and faulty brushing with abrasive oral hygiene products can also increase TW. Individuals unhappy with the color of their teeth may also frequently use whitening toothpaste.

Saliva is considered the biological factor with the greatest potential to modify the progression of TW. There are several potential mechanisms by which saliva may protect enamel from dietary acid erosion. Saliva protection mechanisms include the dilution of erosive agents in the mouth, neutralization, effects of calcium and phosphate ions, and slowing of the rate of enamel dissolution.

The loss of dental tissue can lead to the character's loss of precision and form, and in advanced stages the dentin surface can be exposed. TW is initially painless and unrecognizable. In the next stage, complaints often include tenderness and non-aesthetic factors. It is difficult to recognize the signs of TW and very important to avoid premature diagnosis, as TW can often be diagnosed by a dentist. Correct diagnosis is an important part of the treatment and will help the dentist determine recommendations for the patient.

Eligibility Criteria:
Inclusion Criteria:

Subject is in good health. Subject is able to understand and read the questionnaire.

Exclusion Criteria:

Wearing orthodontic appliances, Having crowns or partial dentures Using any medications.
Counterfactual Thinking and Decision-making in OSA Syndrome

The aim of this research is to verify the ability of counterfactual thinking about medical decisions in individuals with obstructive sleep apnea syndrome when compared with healthy individuals


Eligibility Criteria:
Inclusion Criteria:

- Diagnosis of obstructive sleep apnea syndrome, according to the clinical assessment.

Exclusion Criteria:

- Concurrent neurological, neurodevelopmental (e.g., autism), motor, and/or psychiatric disorders
Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients

The study is a non-blinded trial with one single intervention in sick newborn infants. The Neosense umbilical catheter will be used instead of the routinely used umbilical catheter on infants where the treating physician has ordered use of an umbilical catheter. The catheter will be connected to the Neosense monitor/measuring unit.

Blood samples for blood gas analysis are collected from the patients according to the clinical routine (every 4th to 6th hour). Oxygen tension data from the Neosense measuring system, from the time points when a blood gas sample was collected, will be recorded. This data will be compared to the oxygen tension value from the blood gas sample collected at the same time point. The blood gas samples will be analysed according to clinical and laboratory routine.

The infants will remain in the study as long as the Neosense measuring system is used.


Eligibility Criteria:
Inclusion Criteria:

* Sick newborn infants where the clinical routine indicates use of an umbilical catheter. At least one of the criteria below should be fulfilled:

  * The infant needs invasive measurement of blood pressure.
  * The infant needs repetitive sampling of blood.
  * The infant needs prolonged infusion(s) \> 2 days.
  * The infant needs infusion of vessel irritating and potentially vessel harming solutions.
  * The infant is born extremely preterm (before 28+0 weeks gestational age).
  * A newborn infant with severe respiratory disorder, requiring oxygen treatment (more than 40% Fraction of inspired oxygen (FiO2)).
  * The infant is undergoing therapeutic hypothermia following asphyxia ("oxygen deficiency at birth").
  * The infant has a severe infection/sepsis.
* Signed informed consent form by both parents (or guardians), (if the infant has only one parent (or guardian) one informed consent is required).

Exclusion criteria:

* Gastroschisis
* Omphalocele
* Peritonitis
* Necrotizing enterocolitis
* Omphalitis
Retrospective Cohort Observational Study to Evaluate the Effectiveness and Safety of Fresh or Frozen Embryo Transfer

A multicenter, retrospective cohort observational study to evaluate the effectiveness and safety of fresh or frozen embryo transfer after ovarian hyperstimulation (administration of rFSH or HP-hMG alone or co-administration of rFSH and HP-hMG)

A multicenter, retrospective cohort observational study to evaluate the effectiveness and safety of fresh or frozen embryo transfer after ovarian hyperstimulation (administration of rFSH or HP-hMG alone or co-administration of rFSH and HP-hMG) to infertile female patients undergoing assisted reproductive technology to controlled ovarian hyperstimulation

Eligibility Criteria:
Inclusion Criteria:

* First IVF-ET cycle patients

Exclusion Criteria:

Poor ovarian responder

- At least two of the following three features must be present: (i) Advanced maternal age (≥ 40 years) or any other risk factor for Poor ovarian response (POR); (ii) A previous POR (≤ 3 oocytes with a conventional stimulation protocol); (iii) An abnormal ovarian reserve test (i.e. AFC \< 5-7 follicles or AMH \< 0.5-1.1 ng/mL)
Patient and Care Partner Experiences Living With Multiple Myeloma (PaCE-MM)

This research study is explore the impact over time of multiple myeloma and its associated treatments on the physical and cognitive function and quality of life of patients and their care partners and how these impacts affect the overall illness experience.

This study aims to identify the factors, for example, age, race, sex, education, household income, clinical or other geriatric conditions such as depression, anxiety, or lack of social support that can predict those most likely to experience changes in physical and cognitive function and quality of life. Furthermore, patients and care partners experienced challenges, because of multiple myeloma and its associated treatments, will be studied using semi-structured interviews.

Patients will complete baseline geriatric assessments and a 30-45-minute cognitive test, and both will be reassessed in 3 months intervals. The geriatric assessment is primarily patient-reported surveys and involves a multi-domain evaluation of a patient's functional status (i.e., their ability to live independently at home and in the community), co-morbid medical conditions, cognition, psychological status, social functioning and support, medications, and nutritional status. Care Partners will be asked to complete baseline surveys that will also assess their well-being and ability to function at home.

To provide a more comprehensive understanding of the myeloma-related experiences a subset of patients and their care partners will be asked to participate in a baseline interview repeated over time to understand how the disease and its treatments shape the experiences.

Duration of Subject Participation: 6 months

Eligibility Criteria:
Inclusion Criteria:

Patients must meet the following inclusion criteria to participate in this study:

1. Aged ≥55
2. New myeloma diagnosis as defined by the International Myeloma Working Group, does not have another non-myeloma plasma cell disorder such as POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma cell disorder, skin changes) or amyloidosis.
3. Starting systemic treatment.
4. Able to understand and speak in English.
5. Able to provide informed consent to participate.

Care Partners must meet the following inclusion criteria to participate in this study

1. Aged ≥18.
2. Able to understand and speak in English.
3. Able to provide informed consent to participate.
4. Be a care partner for a patient with multiple myeloma and is also enrolled in the assessment portion of this study.
5. Willing and able to participate in semi-structured interviews.

Exclusion Criteria:

1. All participants meeting any of the following exclusion criteria at enrollment will be excluded from the study: Inability to read and speak English.
2. Dementia altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
Virtual Reality vs. Standard-of-Care for Comfort During Laceration Repair

Lacerations are a common reason for presentation to the Emergency Department and children needing laceration repair with sutures are experiencing pain and anxiety.

Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.

This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care in addition to pharmacoanalgesia during a laceration repair procedure. Investigators will measure pain, anxiety, satisfaction, amount of analgesia and the length of procedure and compare between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Children age 6 - \<17 years
* Arriving to the Emergency Department with a chief complaint of laceration
* The managing physician determines need for repair with suture
* Parents will sign a consent form and children will sign an assent form

Exclusion Criteria:

* Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay)
* Triage category 1 (resuscitation)
* Facial features or injury prohibiting wearing VR goggles
Dexmedetomidine and Fentanyl As Adjuvants to Hyperbaric Bupivacaine for the Prevention of Post-spinal Shivering in Hip Arthroplasty Surgeries

The aim of this study is to compare the efficacy of intrathecal dexmedetomidine versus intrathecal fentanyl when added to hyperbaric bupivacaine in the prevention of post-spinal shivering in patients undergoing hip arthroplasty surgeries and to observe their effects as regards to sedation and intensity of the block.

Preoperative settings:

All patients fulfilling the inclusion criteria who are undergoing hip arthroplasty surgeries and receiving spinal anaesthesia will be randomised into 2 equal groups, namely group D (Dexmedetomidine group) and group F (Fentanyl group).

Routine pre-operative assessment will be done for all patients including routine history taking, clinical examination, and laboratory investigations (complete blood picture, kidney function tests, liver function tests, prothrombin time, partial thromboplastin time).

An informed written consent will be taken from every patient just before the surgery.

Intraoperative and postoperative settings:

On arrival to the operating room, baseline parameters such as ECG, mean arterial blood pressure, heart rate, and oxygen saturation will be recorded. All the patients will be preloaded with 10 ml/kg of Ringer's solution through peripheral intravenous cannula and monitored with five leads electrocardiography, pulse oximetry, and non-invasive blood pressure (NIBP) (which records systolic, diastolic, and mean blood pressure every 5 min intraoperatively and every 15 min in the recovery room, heart rate was recorded in the same intervals).

Under complete aseptic technique, local anaesthetic in the form of 3 ml of lidocaine 2% will be given at the site of spinal injection. Subarachnoid block will be administered in the sitting position midline approach with 25 gauge (Quincke needle) at L3-L4/L4-L5 space.

For group D, the preservative-free dexmedetomidine 100 μg/ml will be loaded into a 100-unit insulin syringe (1 μg/unit) and 5 units will be added to 4 ml (20 mg) of 0.5% hyperbaric bupivacaine.

For group F, fentanyl 25 mcg will be given intrathecally added to 4 ml (20 mg) of 0.5% hyperbaric bupivacaine.

Patients will be immediately placed in the supine position after completing the spinal block.

Eligibility Criteria:
Inclusion Criteria:

* ASA I, ASA II or ASA III patients scheduled for hip arthroplasty surgeries under spinal anaesthesia.

Age \> 20 years.

Exclusion Criteria:

* Patient refusal

  * Patients with known neurologic and psychiatric illness.
  * Contraindications for spinal anaesthesia as bleeding or coagulation test abnormalities, local skin infection at spinal lumbar region, raised intracranial pressure and hypovolemia.
  * Height \<150 cm.
  * Systemic disorders like hematological, respiratory, cardiac, renal or hepatic insufficiency.
  * Allergy to any of the drugs used in the study.
Evaluating Blood Glucose Levels During Infusion With HepaGam B (HBIG) in Post-liver Transplant Patients

HepaGam B Hepatitis B Immune Globulin (HBIG) solution contains 10% maltose, which could possibly interfere with the measurement of glucose levels when using glucose non-specific tests. The purpose of this study is to determine whether use of HepaGam B HBIG shows an increase in glucose levels in the body using non-specific glucose monitoring, as well as specific glucose monitoring. The sponsor believes that this medication will not cause a significant increase in glucose levels in the body when measured by glucose non-specific tests.

BACKGROUND:

Hepatitis B Immune Globulin (HBIG) is used post liver transplantation (OLT) in hepatitis B surface antigen-positive recipients to prevent recurrence of hepatitis B. One formulation of HBIG, HepaGam B, contains the disaccharide maltose, which can potentially falsely elevate glucose readings when glucose nonspecific point of care (GNSPOC) testing is used, such as a glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ)-based method. This can result in inappropriate administration of antidiabetic agents and resultant episodes of clinically significant hypoglycemia. Glucose specific point of care (GSPOC) testing, such as a glucose oxidase-based method, however, is not affected by the presence of maltose. The purpose of this study was to determine if there was a significant difference in glucose readings using GSPOC and GNSPOC monitoring devices after HBIG administration.

METHODS:

This is a nonrandomized, prospective study evaluating patients receiving maintenance HBIG therapy over 3 months post liver transplantation. Blood glucose levels in each subject were analyzed by GSPOC and GNSPOC devices at specific times around HBIG administration.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* HBsAG positive candidates for HBV related liver transplant to be placed on HepaGam B therapy for the prevention of HBV recurrence in both the acute phase (immediately post operative) and the long term maintenance phase
* at least 18 years of age

Exclusion Criteria:

* unable or unwilling to provide written informed consent
* concomitant administration of other maltose containing products such as dietary supplements, dietary aids, IVIG, external peritoneal dialysis solution in both arms
* concomitant administration of corticosteroids in the long term maintenance phase
* pregnancy, as determined by a pregnancy test administered after consent has been signed
Presence of IBD Specific Antibodies (ASCA, ALCA, ACCA, AMCA) in the Sera of Patients With Spondyloarthropathy

A relationship between IBD and spondyloarthropathy is well recognized. ASCA ( anti saccharomyces cerevisiae antibodies)are considered to be a serological marker for Crohn's disease and have been studied in patients with spondyloarthropathy with conflicting results. More recently, new serological markers for IBD have been described. These markers are antibodies to certain defined glycans , and their use may permit an improved diagnosis of IBD.

The aim of our study is to investigate wether these new serological markers are present in the sera of patients with spondyloarthropathy.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of psoriatic arthritis, ankylosing spondylitis, or undifferentiated spondyloarthropathy

Exclusion Criteria:

* diagnosed inflammatory bowel disease