cyrilzakka/clinical-trials huggingface dataset:
Vitamin E to Prevent Mucositis in Children With Cancer

The primary objective is to determine whether in children undergoing doxorubicin-containing chemotherapy, if topical vitamin E, when compared to placebo, decreases an objective measurement of oral mucositis.

Oral mucositis is a common consequence of chemotherapy and is an important sequela of cancer therapy because it is painful and affects quality of life, may lead to hospitalization for hydration or pain control, and provides a portal of entry for oral microflora. In addition, oral mucositis has become a major dose-limiting toxicity and consequently, may limit delivery of anti-cancer therapy.

Despite the frequency of mucositis, there are no feasible therapies proven to be successful in preventing mucositis in children. Vitamin E is a fat-soluble essential vitamin that may protect against doxorubicin-induced oral mucositis through its anti-oxidant properties.

In this study, we will examine the efficacy of topical vitamin E as prophylaxis against chemotherapy-induced mucositis with a novel methodology appropriate for the study of rare conditions, namely combining N-of-1 trials using Bayesian meta-analysis.

The primary outcome is an objective mucositis score measured on days 7, 10, 14 and 17. Secondary outcomes included daily pain and swallowing visual analogue scale scores, and World Health Organization mucositis scores collected on days 5 to 20.

Comparisons: Objective and subjective mucositis scores will be compared in cycles associated with topical vitamin E versus cycles associated with placebo administration. We will use repeated measures analysis within a Bayesian framework in order to conduct this comparison.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of cancer and treated at the Hospital for Sick Children, Toronto, Canada
* planned chemotherapy includes at least two identical courses of doxorubicin-containing chemotherapy in which the dose of doxorubicin was at least 60 mg/m2 per course
* at least 6 years of age and less than 18 years
* lives in the Greater Toronto area

Exclusion Criteria:

* allergy to vitamin E or placebo ingredients
* child is unable to comply with topical vitamin E application
* cild is receiving head or neck irradiation
Uro-NIRS Clinical Study

The purpose of this experiment is to confirm the results of previous testing of Urodynamix's Uro-NIRS device. Together Urodynamix and Laborie have created a device that includes standard Laborie medical equipment and the experimental Urodynamix device. Collectively this integrated device is considered an investigational device, and the results from this study may be used to support a submission to the US Food and Drug Administration for the approval of the integrated device.

This research is being done because we want to test the ability of the integrated Laborie and Urodynamix device to provide a non-invasive method to provide additional information to assist with the diagnosis of or treatment plan of patients suffering from urinary problems. The current technologies rely solely on the measurement of internal pressures of the bladder, which involves the insertion of catheter into the subject's urethra.

This is a study of the fully integrated Uro-NIRS:UDS device (Laborie Triton or Laborie Dorado and Urodynamix's Non-Invasive Urodynamics device - Uro-NIRS), to confirm the results using the fully integrated Uro-NIRS:UDS device as compared to the stand-alone URO-NIRS device and UDS device. The study will evaluate male patients with lower urinary tract symptoms (LUTS) and female subjects with over-active bladder (OAB).

The Uro-NIRS unit uses near infrared light at 3 different wavelengths to measure changes in haemoglobin and cytochrome from the detrusor muscle from the human bladder wall. This process is similar to what is used for cerebral and muscle oxygenation monitoring (e.g., pulse oximetry). Previous clinical feasibility studies have identified the correlation between the changes in haemoglobin and cytochrome and the pressure values obtained during urodynamics procedures and uroflow procedures.

For this study the Uro-NIRS results specifically will not be used by the urologist/nurse to guide in patient management and treatment decisions, but rather will only be used to collect measurements from the patient. The Uro-NIRS sensor patch will be adhered to skin surface where their bladder is located.

The study will be conducted by the two principal investigators at the two clinical study sites who will collectively enrol a minimum of 50 subjects, with a minimum of 35 male subjects and a maximum of 15 female subjects. The study enrolment objective is to equally enrol male subjects into three categories: unequivocal, obstructed and unobstructed. Female subjects shall all have OAB.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 18 years of age or older.
* Subjects are patients of one of the institutions and are currently scheduled for UDS
* Male subjects must have LUTS
* Female subjects must have OAB
* Subjects must give their informed consent prior to enrollment.

Exclusion Criteria:

* The patient has an existing health condition which the investigators feel will not allow for safe or accurate measurements with the Uro-NIRS:UDS device.
Role of Montelukast in Asthma and Allergic Rhinitis Patients

To determine the effect of Montelukast in Asthma and Allergic rhinits patients

Montelukast is a potent and selective blocker of the CysLT1 receptor. Accordingly, a recent study has shown that Montelukast can improve symptoms of seasonal allergic rhinitis and asthma in patients with both diseases. For treatment of asthma, Montelukast is administered once daily to adults as a 10-mg film-coated tablet, to children aged 6-14 years as a 5-mg chewable tablet, and to children aged 2-5 years as a 4-mg chewable tablet form. Asthma and allergic rhinitis have been linked clinically for many years as "one airway one diseases". Patients with allergic asthma and rhinitis are significantly more likely to experience asthma attacks compared to patients with asthma alone. Side effects most commonly reported above placebo included headache, otitis media, upper respiratory infection, and pharyngitis

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Signed Informed Consent
* Clinical diagnosis of Asthma and Allergic Rhinitis

Exclusion Criteria:

* Previous adverse reaction to Montelukast
* History of hyper-eosinophilic disorder other than atopic disease
* Female subjects who are pregnant, breast-feeding
* Any significant and active pulmonary pathology other than asthma
Pharmacological Activation of HMN for OSA Aim 2

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of LTM1201AZ, LTM1201AT, LTM1201AD, LTM1201AG administered before sleep on OSA phenotype traits and OSA severity during sleep.


Eligibility Criteria:
Inclusion Criteria:

* AHI \> 10 events/h during NREM supine sleep

Exclusion Criteria:

* Any medical condition other than well controlled hypertension and mild diabetes.
* Any medication known to influence breathing, sleep/arousal, or muscle physiology.
* Claustrophobia.
* Inability to sleep supine.
* Allergy to any of the medications tested in the protocol.
* History of kidney stones, hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis D.
* Individuals with underlying cardiac disease, such as arrhythmias.
* Individuals taking psychiatric medications, such as an MAO-I, SSRI or SNRI, or any of the studied medications for medical care.
* For women: Pregnancy.
* Pulmonary hypertension
* Severe OSA with a mean SaO2 lower than 88%
Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age

This study will evaluate the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS). Ceftobiprole is an antibiotic which belongs to a group of medicines called 'cephalosporin antibiotics'. It is approved for its use to treat adults and children with pneumonia in many European and non-European countries.

This is a multicenter, open-label, single-arm, multiple-dose study of intravenous (IV) ceftobiprole medocaril (prodrug of the active moiety ceftobiprole). It may be combined with ampicillin and/or an aminoglycoside based on the Investigator's judgement according to manufacturer's instructions and/or local standard of care.

Following screening, ceftobiprole will be administered as a 2-hour infusion at a dose of 7.5 mg/kg every 12 hours to 15 mg/kg every 8 hours, depending on age and weight.

The target treatment duration is 3-10 days, which may be extended to 14 days if considered clinically necessary by the Investigator.

Eligibility Criteria:
Key Inclusion Criteria:

* Informed consent from parent(s) or other legally acceptable representative (LAR) to participate in the study
* Male or female, with a gestational age of ≥ 24 weeks and a post-natal age ranging from ≥ 3 days to ≤ 3 months
* Diagnosis of documented or presumed bacterial LOS requiring administration of systemic antibiotic treatment
* Sufficient vascular access to receive study drug and to allow blood sampling at a site separate from the study drug infusion line

Key Exclusion Criteria:

* Refractory septic shock not responding to 60 minutes of vasopressor treatment within 48 hours before enrollment
* Proven ventilator-associated pneumonia
* Proven central nervous system infection (e.g., meningitis, brain abscess)
* Proven osteomyelitis, infective endocarditis, or necrotising enterocolitis
* Impaired renal function or known significant renal disease, as evidenced by an estimated glomerular filtration rate (using the Schwartz formula or other applicable formula) calculated to be less than 2/3 of normal for the applicable age group, OR urinary output \< 0.5 mL/kg/h (measured over at least 8 hours), OR requirement for dialysis
* Progressively fatal underlying disease, or life expectancy \< 30 days
* Use of systemic antibacterial therapy for longer than 72 hours within 7 days before start of study medication
* Participation in another clinical study with an investigational product within 30 days of enrollment in the current study
Erector Spinae Plane Block for Peri-operative Pain Management in Pediatric Open Pyeloplasty Cases

Regional anesthesia decreases the need for intravenous analgesia in the peri-operative period. Erector spinae plane (ESP) and transversus abdominus plane (TAP) blocks are two common regional anesthesia techniques shown to be effective in open abdominal surgeries. We aim to compare effectiveness of ESP block with TAP block for peri-operative analgesia in pediatric open pyeloplasty patients with a flank incision.

Regional anesthesia for effective post-operative pain management is a part of the pediatric Enhanced Recovery After Surgery (ERAS) protocol. Epidural anesthesia is the gold standard for analgesia for open abdominal surgeries, however difficulties in application and possible complications deter clinicians from utilizing this method. Safe and effective alternatives to epidural anesthesia has been a critical and popular focus of clinical research in recent years. Transversus abdominus plane (TAP) block is an alternative technique shown to be effective in pediatric open abdominal surgeries.

Erector spinae plane (ESP) block was described as an effective block for multi-dermatome pain after thoracic surgery. It is emerging as a safe and easy-to-perform alternative to epidural anesthesia for pelvic, abdominal and thoracic surgery.

During an open pyeloplasty, the flank incision goes through the transversus abdominus plane, where the local anesthetic is injected for TAP block. This may weaken the analgesic effect of the block. In the ESP block, local anesthetic diffuses cranio-caudally through the fascia of erector spinae muscles and the flank incision does not disturb this plane. We aim to compare the effectiveness of ESP block with TAP block in open pyeloplasty patients.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist class I, II or III
* Patients scheduled for elective open pyeloplasty surgery

Exclusion Criteria:

* Local anesthetic allergy or other contraindication to local anesthetic use
* Coagulation disorders
* History of chronic pain
* Patient/Family refusal
* History of scoliosis, spinae bifida, abdominal wall defect
* Past surgical procedures with abdominal wall incision
* Plan to extend the flank incision for additional surgical intervention
Aripiprazole for Neuroleptic-Induced Tardive Dyskinesia

The aim of the present study was to investigate the efficacy of aripiprazole in management of pre-existing neuroleptic-induced tardive dyskinesia

Objective:A few case reports on the use of aripiprazole in neuroleptic-induced tardive dyskinesia have demonstrated positive effects. However its effectiveness in treatment of TD was still inconclusive. The aim of the present study was to investigate the efficacy of aripiprazole in management of pre-existing neuroleptic-induced tardive dyskinesia.

Method: Subjects with pre-existing neuroleptic-induced tardive dyskinesia were chosen from Taoyuan psychiatric center. Patients recruited would be treated with aripiprazole for cross-titration with previous antipsychotics in 8 weeks. We use AIMS, SAS, \& BAS to assess the severity of TF and EPS. We record subjects' age, sex, and other factors which have influence at the treatment response. Subjects are assessed every two weeks in the first month and then monthly until six months.

Eligibility Criteria:
Inclusion Criteria:

* Female patients must agree to prevent from being pregnant during trial periods
* Meet psychotic disorder or mood disorder criteria of DSM-IV
* Patients must have psychiatric diseases that need to use antipsychotics for a long time
* They must meet DSM-IV research criteria for neuroleptics induce tardive dyskinesia
* No clinical significant major systemic diseases
* No special neurological diseases which would influence the assessment for EPS or TD
* Mentality is better than mild mental retardation
* Patients or .legal representatives agree to join in the research and sign informed consent.

Exclusion Criteria:

* Unstable major systemic diseases
* Had neurological disorder influenced to EPS assessment
* Substance abuse or dependence other then coffee or tobacco within 6 months before study
Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma

This is a randomised, open-label, multi-centre, Phase II study in patients with newly diagnosed glioblastoma.

62 patients with newly diagnosed glioblastoma are enrolled in the study in a 1:2 allocation (standard of care (SOC): ALECSAT as an adjunct therapy to SOC).

Patients recruited into this study will receive either:

* ALECSAT as an adjunct therapy to standard of care for newly diagnosed glioblastoma (first line therapy: Stupp regimen, followed by second line therapy at the Investigator's discretion) or
* Standard of care therapy for newly diagnosed glioblastoma (first line therapy: Stupp regimen, followed by second line therapy at the Investigator's discretion).


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, aged between 18 and 70.
* Histologically confirmed glioblastoma (Grade IV) diagnosis.
* Eligible for combined radiotherapy and TMZ treatment.
* Patients with complete or partial tumour resection. For patients with limited tumour volume, biopsy is acceptable.
* WHO Performance status 0-2.
* Body weight ≥ 40 kg (males), ≥ 50 kg (females).
* Able and willing to provide written informed consent and comply with the study protocol and procedures.
* Women of child-bearing potential must have a negative pregnancy test at screening and agree to use acceptable methods of contraception during the trial.

Exclusion Criteria:

* Prior treatment for brain tumours at study entry.
* Prior treatment with temozolomide at study entry.
* Females who are pregnant, planning to become pregnant or breastfeeding.
* Positive tests for anti- human immunodeficiency virus (HIV)-1/2; HBsAg, anti HBc, anti-HCV or being positive in a Treponema Pallidum test (syphilis).
* Patients who may have been exposed to West Nile virus or Dengue fever virus within the last 28 days prior to enrolment or Ebola virus within the last 60 days prior to enrolment should be excluded, unless the patient has been tested negative.
* Patients from high incidence areas for Human T-Lymphotropic Virus (HTLV-1) virus or who has a parent or spouse from a high incidence area must be excluded unless tested negative for HTLV-1 virus.
* Known allergy to study medication.
* Any condition or illness that, in the opinion of the Investigator or medical monitor, would compromise patient safety or interfere with the evaluation of the safety of the investigational drug.
* Any concurrent illness that may worsen or cause complications in connection with blood donation, for example uncontrolled epilepsy, cardiovascular, cerebrovascular or respiratory disease.
* Use of immunosuppressant drugs with the exception of steroids. Blood transfusion within 48 hours prior to the donation of blood for ALECSAT production.
* Low haemoglobin count in the opinion of the Investigator.
* Lymphocyte count \<0.3 x 109/litre.
* Participation in any other interventional clinical trial within 30 days prior to inclusion.
* TMZ contraindication.
A Comparative Analysis of Intertransverse Nerve Block and Paravertebral Nerve Block in Endoscopic Hepatectomy

This study aims to compare the analgesic effect of intertransverse nerve block and paravertebral nerve block after endoscopic hepatectomy, evaluate its effectiveness and safety, and provide new ideas and clinical basis for postoperative pain management of liver surgery.

This study was a prospective, double-blind, randomized controlled trial. Patients who were eligible for laparoscopic partial liver resection in our center were included, with intertransverse nerve block as the experimental group and paravertebral nerve block as the control group. Through the analysis of postoperative pain score 30min to 24h, the number of effective analgesic pump compressions within 24h, the amount of analgesic drugs used, complications and other data, To evaluate the efficacy and safety of intertransverse nerve block in patients undergoing laparoscopic partial liver resection.

Eligibility Criteria:
Inclusion Criteria:1:

1.18-80 years old adult, BMI\<27.9kg/m2

2: 2. American Society of Anesthesiologists ASA Grade I-III

3: 3. Patients with laparoscopic partial liver resection such as liver tumors

4: 4. Willing to participate in this study and sign the informed consent form

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Exclusion Criteria:

1. 1. The patient or family member refuses to sign the informed consent form
2. 2. Blood coagulation dysfunction, local infection
3. 3. Those who have communication, communication disorders or mental abnormalities
4. 4. Patients with severe heart, pulmonary and renal insufficiency or patients with central system diseases
5. 5. For any reason, it cannot be matched with the study or the researcher believes that it is not appropriate to be included in this experiment.

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Comparison of Pre-exercise Beta-hydroxy-beta-methylbutyrate Free Acid (HMB-FA) and Cold Water Therapy for the Attenuation of Muscle Damage and Soreness

Study Objectives

1. Compare beta-hydroxy-beta-methylbutyrate free acid (HMB-FA) to cold water immersion on performance recovery from an acute bout of high intensity resistance exercise.
2. Compare HMB-FA + Cold water immersion to HMB-FA or cold water immersion.
3. Examine the effect of these recovery modalities on markers of muscle damage, inflammation and immune function.

Subjects

Subjects (men and women, 18 - 35 y) with at least one year of resistance training experience will be recruited. Subjects will be randomly divided into one of four groups: a cold water immersion group (CW), HMB-FA, CW+HMB-FA and a control group (CT).

Study Protocol

Subjects will report to the Human Performance Laboratory (HPL) on four separate occasions. On the first visit (T1) subjects will be tested for maximal strength \[one repetition-maximum (1-RM)\] on the squat, dead lift and barbell lunge exercises.\] On their second visit (T2) subjects will perform a lower body resistance exercise session consisting of four sets of the squat, dead lift and barbell lunge exercises. All subjects will then report back to the HPL at 24- (T3) and 48-hours (T4) post-exercise. During T3 and T4, subjects will perform four sets of the squat exercise only using the same loading pattern and rest interval length as T2. Following the T2 and T3 workouts subjects in CT will undergo no treatment; subjects in CW will be required to sit in a whirlpool tub for 10-min up to their umbilicus in water at 50° F - 54° F (10° C - 12° C); subjects in HMB-FA will be provided the supplement 30 min prior each workout and CW+HMB-FA will be administered together at time points describe above.

Statistical Analysis

Statistical evaluation of performance and biochemical changes will be accomplished using a repeated measures analysis of variance (ANOVA).


Eligibility Criteria:
Inclusion Criteria:

* At least one-year of resistance training experience
* Free of any physical limitations (determined by health and activity questionnaire).
* Between the ages of 18 and 35

Exclusion Criteria:

* Inability to perform physical exercise (determined by health and activity questionnaire)
* Taking any other nutritional supplement or performance enhancing drug (determined from health and activity questionnaire).
* Any chronic illness that causes continuous medical care
* Taking any type of prescription or over-the-counter medication, having any chronic illness causing you to seek medical care, pregnancy
Experimental Research on Deep Carious Lesion Treatment of Molars

Maintaining dental pulp vitality is crucial for tooth preservation and functionality. Untreated dental caries may lead to pulp necrosis and infection, affecting children's growth and well-being. The first permanent teeth erupt around 6 years old. These are the first molars (FPM), which are frequently affected by caries, soon after their eruption.

In the present application, our main goal is to determine whether two treatment groups (MTA and TheraCal) are long-term effective in preserving pulp vitality among children' FPM affected by deep caries.

Among the most frequently used materials for pulp capping are calcium hydroxide, mineral trioxide aggregate (MTA), and, more recent, TheraCal. All of them are biocompatible and induce the formation of coronal hard tissue barriers (tertiary reparative dentin). Calcium hydroxide, considered for a long time the gold standard of direct pulp capping materials, has excellent antibacterial and remineralisant properties; however, it lacks adhesion, especially at moist dentin, and reparative dentin is less homogenous.

MTA proved to stimulate protective dentin bridge formation without inflammatory changes and least necrosis. It is also moisture tolerant, but it is more expensive, has poor handling characteristics and slow setting time.

TheraCal bonds to deep moist dentin, has strong physical properties, no solubility, high radioopacity and higher calcium releasing abilities than MTA or calcium hydroxide.

Eligibility Criteria:
Inclusion Criteria:

* untreated deep uncomplicated carious lesions in first permanent molars (FPM)
* absence of clinical diagnosis of pulp exposure
* fistula
* swelling of periodontal tissues
* abnormal tooth mobility
* history of spontaneous pain or sensitivity to percussion
* healthy appearance of adjacent gingiva
* normal tooth color
* positive vitality to thermal and electric tests.

Exclusion Criteria:

* FPM with previous treatment
* FPM with developmental abnormalities (such as enamel hypoplasia, dentinogenesis imperfecta etc.)
* children with mental disabilities or systemic diseases.