cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Multisensoral Nature-based Intervention in Hospitalized Children During Venous Blood Sampling

This randomized controlled trial (RCT) study aims to evaluate the effectiveness of multisensoral nature-based intervention compare to standard care in relieving anxiety, fear and pain in hospitalized child aged 5 to 9 years and parent's anxiety and satisfaction during venous blood sampling. The assessment uses different measures to assess child's anxiety, fear, pain and parent's anxiety and satisfaction during venous blood sampling.

The RCT study aims to evaluate the effectiveness of multisensoral nature-based intervention compare to standard care in relieving anxiety, fear and pain in hospitalized child aged 5 to 9 years and parent's anxiety and satisfaction during venous blood sampling. The intervention includes a multi-sensory nature experience using natural materials and a virtually created natural environment. The study will include children and parents in the intervention group (N=53, receiving the multisensoral nature-based intervention) and children and parents in the control group (N=53, receiving usual care). The children's blood sampling will be videotaped. The assessment uses different measures assess to child's anxiety (mYPAS = The modified Yale preoperative anxiety scale), child's fear (CFC = Children Fear Scale), child's pain (FAS = Facial Affective Scale), parent's anxiety (STAY-Y1 = The State-Trait Anxiety Inventory) and satisfaction (VAS = Visual Analogue Scale) during venous blood sampling. In addition, heart rate (HR) measurement are used to assess the child's anxiety, fear and pain. The data will be analysed using statistical methods.

Eligibility Criteria:
Inclusion Criteria:

1. The child is aged between 5 and 9 years old
2. The child has a long-term illness (such as diabetes or rheumatism)
3. The child has previous experience of venous blood sampling
4. The child's level of development is age-appropriate (such as, the child is cared for at home or in day care/day nursery or attends school in the same level as the other children)
5. Child and parent understand and speak the Finnish language

Exclusion Criteria:

1. The child has a diagnosis of abnormal neurological development (such as, a child has difficulty understanding spoken language or expressing emotions)
2. The child has chronic pain that has lasted more than 3 months and requires strong painkillers (opiates).
3. The child undergoes an examination or treatment during a check-up at the outpatient clinic that requires medical treatment similar to anesthesia
4. The child is taking a sedative medication.
Effect of a Sugar-free Isotonic Drink on Different Health Bioparameters

Randomized clinical trial in which 160 participants (80 men, 80 women) will be assigned to one of two groups (40 participants per group), to determine the effects of isotonic drink on different health parameters, following published recommendations. Subjects will be electronically randomized by block design into two arms: an experimental group: isotonic drink and a control group (placebo): normal water.


Eligibility Criteria:
Inclusion Criteria:

* men and women aged \&amp;gt;18 years;
* body mass index (BMI) of 18 to 25 kg/m\^2;

Exclusion Criteria:

* individuals who have taken medication up to 3 months before the start of the study or supplements during the study;
* individuals with a history of gastrointestinal pathology or disorder such as duodenal ulcer, chronic colitis, or chronic inflammatory disease/surgery of the gastrointestinal tract (Crohn\&amp;#39;s disease, ulcerative colitis), celiac disease, or irritable bowel syndrome;
* individuals with serious acute or chronic diseases, treatments, or recent surgery;
* individuals with a report of serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) above the upper limit of the reference interval.
Use of the PercSys MicroStent Device to Alleviate Ureteral Stone Symptoms and Hydronephrosis

Kidney stones cause severe pain. Patients with a stone lodged in the ureter (the tube that drains the bladder), require urgent treatment with a stent to relieve the blockage. This tube, or ureteral stent, gives the patient relief until they can have their stone treated. This study is to evaluate a new type of ureteral stent to relieve pain from kidney stones. This stent is designed to drain the kidney and unlike other ureteral stents, is also designed to widen the ureter to help the stone pass on its own.

This study is to evaluate a new type of ureteral stent to relieve kidney obstruction from a stone lodged in the ureter. This stent would be placed when a patient presents with pain in the Emergency Room or clinic in a patient that has no signs of infection. It is designed to continue drainage of the kidney and unlike other ureteral stents, is also designed to help dilate the ureter to facilitate spontaneous stone passage. This means the stent may also be therapeutic and the patient would be less likely to undergo another procedure to have the stone removed. Research performed at the Stone Centre at VGH shows that in ex vivo pig kidneys, this stent provides very good urinary drainage of the kidney. This has been published in a peer-reviewed journal (Lange D, Hoag NA, Poh BK, Chew BH. Drainage characteristics of the 3F MicroStent using a novel film occlusion anchoring mechanism. J Endourol. 2011 Jun;25(6):1051-6.).

Eligibility Criteria:
Inclusion Criteria:

1. Perforation of the urinary tract;
2. Acute hemorrhage;
3. Tissue trauma;
4. Edema;
5. Submucosal tunneling of guidewire or device during advancement; and
6. Protein encrustation of the device.

   Exclusion Criteria:
7. Infection;
8. Hemorrhage;
9. Complications associated with the use of anesthesia,
10. Perforation of the urethra or bladder,
11. Scarring or stricture of the urethra; and
12. Urinary retention due to urethral edema.
Impact of Anticoagulants and Antiplatelets in Patients on Transurethral Resection of the Prostate

Benign prostatic hyperplasia(BPH) is a common disease in urology among old men. If BPH symptom cannot be controlled by drugs, then transurethral resection of the prostate (TURP), is recommended. Although the procedure is quit safe, these old men often take anticoagulants and antiplatelets to control cardiovascular diseases, which arose some concerns for their bleeding risk. The management of anticoagulation in patients undergoing surgical procedures is challenging because interrupting anticoagulation increases the risk of thrombotic events. At the same time, surgery and invasive procedures have associated bleeding risks that are increased by the anticoagulant administration. Now, the recommendation about anticoagulants and antiplatelets discontinuation had no concrete evidence, especially in TURP. Furthermore, there is no relative studies done in Taiwan population, which calls for further investigation.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to National Cheng Kung University Hospital Urology during the study
* Older than 20 years old
* Agree to participate this study
* Receiving transurethral resection of the prostate for benign prostatic hyperplasia or prostate cancer

Exclusion Criteria:

* Poor expression ability and without close care givers to answer questions
A Phase I Study in Healthy Volunteers to Assess the Effect of Cytochrome3A4 (CYP3A4) Inhibitors (Diltiazem and Itraconazole) on the Pharmacokinetics (PK) of AZD3293 and the Effects of AZD3293 on the Pharmacokinetics of Midazolam, a Cytochrome 3A4 and Cytochrome 3A5 (CYP3A4/CYP3A5) Substrate

This study is a single-center, open-label, 3-group, fixed-sequence drug-drug interaction study to assess the effect of coadministration of multiple-dose itraconazole or diltiazem on the single-dose PK of AZD3293 and the effects of coadministration of single- and multiple-dose AZD3293 on the single-dose PK of midazolam. The study will also evaluate the safety and tolerability of single and multiple oral doses of AZD3293, alone and in combination with itraconazole, diltiazem, and midazolam in healthy young subjects.AZD3293 is being developed for the treatment of Alzheimer's disease


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written, and dated informed consent prior to any study-specific procedures Male and nonfertile female healthy subjects, aged 18 to 55 years at the time of consent
* Body weight ≥50 to ≤100 kg and body mass index (BMI) ≥19 to ≤30 kg/m2
* Clinically normal findings on physical examination in relation to age, as judged by the Investigator
* Male healthy subjects must be willing to use barrier contraception, ie, condoms, even if their partners are post-menopausal, surgically sterile, or using accepted contraceptive methods, from the first day of dosing until 3 months after the last dose of investigational product (IP)

Exclusion Criteria:

* Participation in any prior study of AZD3293
* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, may influence the results, or may limit the subject's ability to participate in the study
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), as assessed by the Mini-International Neuropsychiatric Interview (MINI)
Oral Nutritional Supplementation in Children at Risk of Undernutrition

The objective of this randomized, controlled trial is to evaluate the effects of consuming a pediatric oral nutritional supplement (ONS) plus dietary counseling for 120 days on anthropometric growth, strength, and nutritional status, compared with dietary counseling alone in undernourished children in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Child is 36 months - 107 months of age.
* Child is undernourished as determined by BMI for age z-score or Mid-upper-arm circumference z-score
* Child's caregiver has voluntarily signed and dated an informed consent form (ICF), approved by an IRB, and provided Health Insurance Portability and Accountability Act (HIPAA) or other applicable privacy regulation authorization prior to any participation in the study.
* Child's caregiver is willing to abstain from providing non-study oral nutrition supplements during the study period duration.
* Child's caregiver is able and willing to follow study procedures and record data in parent diaries and complete any forms or assessments needed during the study.
* Child is willing to consume the study product for the duration of the study, if randomized to intervention group

Exclusion Criteria:

* Child has a height-for-age z-score ≥ 0.
* Child is currently drinking an oral nutritional supplement (ONS) on a regular basis (≥ 15 days in the past month)
* Child is participating in another study that has not been approved as a concomitant study by AN.
* Child has been diagnosed with the following:

  * Galactosemia, or an allergy or intolerance to any ingredient found in the study product
  * Acute or chronic infections including but not restricted to respiratory infections, diarrhea, Hepatitis B or C, HIV infection or tuberculosis
  * Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis
  * Neoplastic, renal, hepatic or cardiovascular, hormonal or metabolic disorders, Down's syndrome or significant, uncorrected cardiac anomalies that may impact growth
  * Infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or a developmental delay that is considered too severe for participation
  * Disorders of hemoglobin structure, function or synthesis
  * Clinically significant nutritional deficiency requiring specialty nutritional therapy
  * Any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.
The Effects of a Virtual Yoga Program on Patients With Chronic Pain

This research is being done to determine if remote yoga-based exercise can help reduce chronic pain. It will include three virtual research visits. This cohort study will include three remote research visits and an online questionnaire administration. In addition, participants will attend 8 weekly virtual yoga sessions with a daily 30-minute "homework assignment" of 30 minutes of video-guided yoga practice.


Eligibility Criteria:
Inclusion Criteria:

* chronic pain for \> 6 months' duration
* on stable doses of medication prior to entering the study and agree not to change medications or dosages (or CAM treatments) during the trial
* have an average pain score of 4/10 or greater over the previous week
* at least mild degree of sleep disturbance, defined as Pittsburgh Sleep Quality Index (PSQI) score \>5
* are able to speak and understand English
* have access to a computer or tablet at home and have an email address
* are not currently engaged in a rigorous daily exercise routine (\>5X/week)
* are willing and physically able to participate in virtual yoga-based exercise

Exclusion Criteria:

* currently under active cancer treatment (chemo, infusion, ongoing radiation)
* acute osteomyelitis or acute bone disease
* current diagnosis of chronic systemic inflammatory diseases including rheumatoid arthritis and lupus
* present or past diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder that would be judged to interfere with study participation
* pregnancy
* any clinically unstable systemic illness judged to interfere with exercise treatment
* a pain condition requiring urgent surgery
* an active addiction disorder, such as cocaine or IV heroin use, that would interfere with study participation
* contraindications to yoga (e.g., severe back or neck injury or surgery)
* regular meditation practice or other meditative practice (e.g tai-chi, meditative form of yoga or contemplative prayer) for \>20 min/week in the past 2 years
* participating in any other therapeutic trial
* other medical condition that would interfere with ability to exercise
Intranasal Fentanyl for the Treatment of Acute Severe Pain on the Pediatric Emergency Department of Mercy Hospital.

The treatment of acute severe pain in pediatric emergencies required a quick and effective therapeutic support. Actually in France, only peripheral venous access or oral therapies with onset of action are commonly used and only few treatments can be used to manage the acute severe pain in children. In June 2017, an intranasal fentanyl use protocol has been established in the pediatric emergency department of Mercy hospital-Metz. The intranasal fentanyl treatment has proved his effectiveness and safe condition in many countries since few years even though has not yet obtained a marketing authorization for use in children in France. In view of the information, parental permission was obtained before the intranasal administration. The efficacy and surveillance data in all patient records of children who benefited this analgesic protocol were retrospectively collected between June 2017 and August 2018. This retrospective study wants to describe the efficacy and safety of intranasal fentanyl on the pediatric emergency department.


Eligibility Criteria:
Inclusion Criteria:

* All patients who received fentanyl intranasal between june 2017 and august 2018

Exclusion Criteria:

* Lack of surveillance data in the medical record of the patient
Risk Factors for Major Complications After Liver Resection

The aim of this study is to determine the risk factors for major complications following liver resection in the setting of a general surgery-teaching department in Morocco, North Africa

Over the past 20 years, the refinement of liver surgery techniques, anesthesiology and perioperative management has dramatically improved the safety of liver resection patients. It has also led to a concomitant extension of indications for a growing number of patients with complex benign or malignant hepatobiliary diseases and/or high risk surgeries.

Published complication rates and risk prediction models and recommendations for patients undergoing liver resection primarily stem from far East or Western high-volume specialized centers. In developing countries, including those in North Africa, specific constraints (e.g., endemic indications, such as liver cystic hydatidosis, blood shortage, and the scarcity of liver surgeons and intensive care providers) may impact liver resection outcomes but they are rarely addressed in the literature.

The aim of this study was to determine the risk factors for major complications following liver resection in the setting of a general surgery-teaching department in Morocco, North Africa

Eligibility Criteria:
Inclusion Criteria:

* all patients who underwent an hepatectomy
* between january 2010 and December 2015

Exclusion Criteria:

* All patient who only underwent liver biopsy with no resection
* Patients non operated
Prognostic Factors for Descending Necrotizing Mediastinitis Development in Deep Space Neck Infections

Descending necrotizing mediastinitis (DNM) is the most serious complication of deep neck infections (DNI) with high mortality. The objective of this retrospective study was to evaluate possible prognostic factors for DNM development in deep space neck infections.

Descending necrotizing mediastinitis (DNM) is the most serious complication of deep neck infections (DNI) with high mortality. The objective of this retrospective study was to evaluate possible prognostic factors for DNM development in deep space neck infections. The study enrolled patients admitted to the Emergency Center of Vojvodina with the diagnosis of multispace DNI with or without DNM either as the primary diagnosis or with discharged diagnosis after surgical treatment during 7-years period. The data were obtained from patient medical records.

Eligibility Criteria:
Inclusion Criteria:

* patients admitted to the hospital due to deep neck infection affecting two or more spaces with or without descending necrotizing medioastinitis
* complete diagnosis and treatment data available from medical charts

Exclusion Criteria:

* incomplete medical data
* infection confined to one deep neck space
* patients treated under local anesthesia
* patients with superficial skin infections
* iatrogenic infections
* infected tumors
Efficacy and Safety of Artesunate-amodiaquine-methylene for Malaria Treatment in Children

Title: Efficacy and safety of artesunate-amodiaquine combined with methylene blue for falciparum malaria treatment in African children: randomised controlled trial.

Design: Mono-centre, two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso.

Phase: Phase II.

Objectives: The primary objective of this trial is to study the efficacy and safety of the triple therapy artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) given over three days in young children with uncomplicated falciparum malaria in Burkina Faso compared to the local standard three days artemisinin-based combination therapy (ACT) AS-AQ regimen.

Population: Children aged 6-59 months with uncomplicated falciparum malaria from Nouna Hospital in north-western Burkina Faso.

Sample size: 180 patients (90 per study arm).


Eligibility Criteria:
Inclusion Criteria:

* 6-59 months old children (male and female)
* Weight ≥ 6kg
* Uncomplicated malaria caused by P. falciparum
* Asexual parasites ≥ 2 000/µl and ≤ 200 000/µl
* Axillary temperature ≥ 37.5°C or a history of fever during last 24 hours
* Burkinabe nationality
* Permanent residence in the study area with no intention of leaving during the surveillance period
* Informed consent

Exclusion Criteria:

* Severe malaria (WHO 2000)
* Vomiting (3 or more within 24 hours before the visit)
* Any apparent significant disease, including severe malnutrition
* A history of a previous, significant adverse reaction to either of the study drugs
* Anaemia (haemoglobin \< 7 g/dl)
* Treated in the same trial before
* All modern antimalarial treatment prior to inclusion (last seven days)
* Simultaneous participation in another investigational study
* Treatment with other investigational drugs
Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline

Because pain is difficult to measure in children, post-operative pain is frequently undertreated in this age range. Pain treatment is required in children due to the high emotional component of pain. Pain is a multidimensional, subjective, perceptual event having a variety of qualities such as intensity, quality, time course, and effects that are perceived differently by each person. Because the operational definition of pain necessitates self-report, pain experienced by children and babies is frequently overlooked, if not ignored.

When general anesthesia is paired with regional procedures, children of all ages are exposed to less intravenous and inhalational anesthetics and analgesics, leaving them nearly free of nausea, vomiting, itching, or unneeded drowsiness. Being completely awake and able to drink soon after surgery, as well as having no issues breathing even after lengthy surgery, are significant benefits that children and parents value.

Caudal block provides the potential benefit of extending the length and effectiveness of the block by combining additional medications with the local anaesthetic agent. Morphine, clonidine, ketamine, and midazolam were among the drugs used.

Although peripheral nerve blocks and caudal anesthesia are relatively safe, extreme attention is required to minimize adverse consequences. Pediatric anesthesiologists must have adequate training to ensure patient safety. A well-trained pediatric anesthesiologist will try to avoid unsafe regional anesthetic application methods and will always be prepared to manage dangerous side effects (overdoses, intravenous administration induced seizures, tip displacement of epidural catheters or centrally located abscesses).

Ketamine is a non-competitive N-methyl D-aspartate NMDA receptor antagonist that is thought to prevent or reverse central sensitization and, as a result, lessen postoperative pain. It also has a peripheral analgesic effect.

Ketamine infiltration has been demonstrated to provide pain alleviation in children having adenotonsillectomy for up to 24 hours following surgery with no adverse effects.

Eligibility Criteria:
Inclusion Criteria:

1- All children whom were diagnosed with herniotomy, orchidopexy, or urethroplasty.

Exclusion Criteria:

1. Drugs used allergy or sensitivity,
2. contraindications to caudal injection, such as infection at the injection site,
3. bleeding disorders
4. caudal vertebral abnormalities