cyrilzakka/clinical-trials huggingface dataset:
Postoperative Vomiting in Children: Comparison Tri - Versus bi -Prophylaxis

The purpose of this study is to evaluate the benefit of addition of droperidol to prophylaxis with ondansetron and dexamethasone in children with high risk of postoperative vomiting (POV). In adults some authors showed that the effectiveness of prophylaxis is correlated to the number of molecules or specific procedures used.

The overall incidence of postoperative vomiting between 25 and 30% for the pediatric population, but it can reach a much higher incidence associated with certain types of surgery, about 80% in some studies like strabismus surgery for example. The identification of patients at high risk of POV is possible through the use of risk score. It is currently only one pediatric validated risk score, but the investigators conducted a multicenter study on this subject, whose results are being analyzed. This should allow us to identify children at high risk of POV. In this targeted population, the prophylaxis should allow a significant reduction in the incidence of POV. In children only one study tried to evaluate the association of ondansetron, dexamethasone and droperidol to prevent postoperative vomiting. However, different doses of the different molecules were combined, the extremely complicated design of this study and important methodological bias do not provide evidence about the superiority of the combination of three anti-emetics compared with two anti-emetics. Our present randomized, double-blind study is designed to compare the effectiveness of Droperidol in combination with a conventional bi-prophylaxis (dexamethasone/ondansetron) to the conventional bi-prophylaxis alone to decrease the occurrence of postoperative vomiting in children at high risk. The combination ondansetron and dexamethasone is frequently assessed as an association to prevent postoperative vomiting also in the adult population and in the pediatric population.

Eligibility Criteria:
Inclusion Criteria:

* Children scheduled for surgery and with high risk of postoperative vomiting, i.e. with VPOP score up to 4
* Between 3 to 18 years
* Informed consent signed or the owner (s) of parental
* Children receiving a social security system

Exclusion Criteria:

* Ambulatory surgery
* Preoperative corticosteroids
* Postoperative sedation
* Allergy known to droperidol, ondansetron or dexamethasone
* Known hypokaliemia
* Known hypomagnesemia
* Bradycardia (\<55 bpm)
* Congenital long QT syndrome
* Treatment that induce prolonged QT
* Pheochromocytoma
* Severe depressive syndrome
A Study of Equfina® on the Incidences of Adverse Drug Reactions in Participants With Parkinson's Disease (Including Participants With Hepatic Impairment)

The purpose of the study is to investigate the incidences of psychiatric symptoms (example, hallucinations), somnolence and sudden onset of sleep, dyskinesia, and retinal degeneration-related events during treatment with Equfina in participants with parkinson's disease (including participants with hepatic impairment).


Eligibility Criteria:
Inclusion Criteria:

1. Participants with Parkinson's disease, who are naïve to Equfina

Exclusion Criteria:

1. Participants previously treated with Equfina
2. Participants who have contraindications on package insert of Equfina
Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma

A Regional, Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Severe Uncontrolled Asthma

This is a regional, multicentre, randomized, double-blind, placebo controlled, parallel group, phase 3 study designed to evaluate the efficacy and safety of 210 mg Q4W (SC) of tezepelumab in adults with severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma controller medication with or without OCS. Approximately 396 participants will be randomized regionally (China/non-China). Participants will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 12 weeks

Eligibility Criteria:
Inclusion Criteria:

* Age. 18-80
* Documented physician-diagnosed asthma for at least 12 months
* Participants who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 6 months.
* Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months.
* At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
* Morning pre-BD FEV1 \<80% predicted normal
* Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening.
* Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.
* ACQ-6 score ≥1.5 at screening and on day of randomization

Exclusion Criteria:

* Pulmonary disease other than asthma.
* History of cancer.
* History of a clinically significant infection.
* Current smokers or participants with smoking history ≥10 pack-yrs.
* History of chronic alcohol or drug abuse within 12 months.
* Hepatitis B, C or HIV.
* Pregnant or breastfeeding.
* History of anaphylaxis following any biologic therapy.
* participant randomized in the current study or previous tezepelumab studies.
Multisensory Integration and Pain Perception

Pain is a predominant disruption of well-being among humans. Feeling pain is a multimodal sensory experience where information is collected and processed from various senses such as sight and touch. Because pain is complex, variable, and experienced differently by each individual, finding more accessible and practical treatments for pain are necessary. Mindfulness meditation (MM) aims to reduce pain by directing focus to perceive thoughts through non-judgmental awareness. Positive reappraisal (PR) is a possible cognitive pain treatment that focuses on changing the meaning of stressful or negative events into positive, benign, valuable, or beneficial. When a stressful event, such as experiencing pain, is positively reappraised, the individual recognizes and engages with the feeling of stress produced by the event and intentionally looks for benefits that change the feeling from negative to positive. The focus of this study is to examine the effect of different cognitive techniques on multimodal innocuous and noxious stimuli. Visual and tactile noxious stimuli will be administered to determine how visual cue integrate to form and modulate the subjective experience of pain. The study team postulates that mindfulness meditation and positive reappraisal will significantly reduce pain in response to multimodal stimulus (visual cue + noxious heat) when compared to a non-manipulation control condition. These findings will be utilized to better understand the multidimensional mechanisms supporting nociception and the cognitive modulation of pain.


Eligibility Criteria:
Inclusion Criteria:

* Native/fluent English speaker
* Ability to understand/willingness to sign consent form

Exclusion Criteria:

* Chronic pain
* Cardiac medications
* Diagnosis of mental illness or personality disorder
* Diagnosis of heart or lung conditions/hyper tension
* Taking psychiatric medications
The Utilization of a Shoe Insert on Individuals with Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance, Biomechanics, and Pain Intensity

We hypothesize that the addition of a unilateral neutral shoe insert combined with standard physical therapy (PT+SI) will have greater improvements in pain and function at 12 weeks and 6 months compared to physical therapy with sham inserts (PT+Sham) and physical therapy (PT) alone. In addition, we hypothesize that the addition of a neutral shoe insert in the involved limb will immediately improve biomechanics and pain with the single-leg stance test.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a history of unilateral hip pain lasting more than three months.
* Subjects with a VAS pain score of at least 3/10 localized to the lateral hip.
* Subjects with pain with palpation to lateral hip.
* Subjects with pain with either resisted hip abduction in relative adduction testing position and/or single leg stance test

Exclusion Criteria:

* Subjects wearing custom foot orthoses at the time of recruitment.
* Subjects who endorse current low back pain ≥ 3 on the NRS or lumbar radiculopathy
* Subjects with a medical history of spinal or lower limb surgery in the past 6 months.
* Subjects with a medical history of total joint replacement of hip, knee, or ankle on the symptomatic side
* Subjects who have had a corticosteroid injection at the hip within the last 12 months;
* Subjects demonstrating clinical signs and symptoms of intra-articular hip joint pathology with ≥ 3/10 groin pain including imaging confirmed significant labral tearing requiring surgery or osteoarthritis \> 2 (mild) on Kellgren-Lawrence score on radiographs.
* Subjects previously diagnosed with systemic inflammatory conditions; active cancer/malignant tumors; or neurological conditions that would affect gait
* Subjects who have had physical therapy within the past 3 months for hip pain
* If subjects are unable to commit to 12 weeks of therapy with one supervised session weekly
* Subjects who have the intention to perform treatments outside of this study including, but not limited to, dry needling or acupuncture, extracorporeal shockwave, therapeutic ultrasound, a TENEX procedure, medication injection therapies, platelet-rich plasma injections, stem cell injections, and surgery.
Studies of a Candidate Aminoquinoline Antimalarial (AQ-13)

This is an initial efficacy study of a candidate antimalarial in human subjects with uncomplicated malaria caused by the most common and most important parasite in Africa (Plasmodium falciparum). This study will enroll 66 adult Malian males with uncomplicated P. falciparum malaria and randomize them to treatment with 1750 mg of the investigational drug (AQ-13) by mouth over 3 days or the current standard treatment, which is 2 doses of Coartem twice daily for 3 days. The hypothesis underlying this study is that AQ-13 will be similarly effective to Coartem for the treatment of uncomplicated P. falciparum malaria due to both chloroquine-susceptible and chloroquine-resistant parasites. Funding Source - FDA Office of Orphan Product Development (OOPD).

This is an initial efficacy study (Phase 2 Proof of Concept Study) of a candidate antimalarial in human subjects with uncomplicated malaria caused by the most common and most important parasite in Africa (Plasmodium falciparum). This study will enroll 66 adult Malian males with uncomplicated P. falciparum malaria and randomize them to treatment with 1750 mg of the investigational drug (AQ-13) by mouth over 3 days or the current standard treatment, which is 80 mg of artemether and 480 mg of lumefantrine twice daily for 3 days. The hypothesis underlying this study is that AQ-13 will be similarly effective to Coartem for the treatment of uncomplicated P. falciparum malaria due to both chloroquine-susceptible and chloroquine-resistant parasites.

Eligibility Criteria:
Inclusion Criteria

1. Adult Malian males ≥ 18 years of age,
2. Uncomplicated malaria with ≥ 2,000 asexual P. falciparum parasites per ul, and
3. Informed consent obtained and signed.

Exclusion Criteria

1. Severe or complicated malaria (including temperature ≥ 40o C),
2. ≥ 100,000 asexual parasites per ul of blood,
3. Anemia or other laboratory results (other than malaria) that require treatment (e.g., Hb ≤ 7 gm/dL, K+ ≤ 3.5 millimolar (mM), BP ≥ 140/90),
4. Seizures or impaired consciousness,
5. Recent antimalarial treatment by history (within ≤ 2 weeks),
6. Chronic medications (including inducers of Cytochrome P450 3A4 \[CYP3A4\] activity such as rifampin and nevirapine),
7. Ventricular or atrial arrhythmias, or second or third degree heart block on the screening ECG or Holter recording,
8. Infection with other plasmodial species on the blood smear (P. ovale, P. ovale, P. vivax).
A Study of MK0657 in Parkinson's Disease Patients (0657-006)

In this clinical trial, the safety of MK0657 when given with levodopa will be assessed in patients with Parkinson's Disease. This study will also measure the effectiveness of MK0657, when given in combination with levodopa, to improve motor symptoms and ameliorate dyskinesias (uncontrolled movements of a part of the body) as compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's Disease patients between the ages of 40 and 80 inclusive
* Patient is in general good health based on screening assessments
* Patient is willing to discontinue anti-parkinson's medications at least 8 hours prior to dosing
* Patient is levodopa responsive with levodopa-induced peak-dose dyskinesias
* Patient taking selective serotonin inhibitors (SSRIs), sleep medications and neuroleptics, have been on a stable dose for at least 30 days and has not experienced any CNS-related side effects
* Patient is not a heavy smoker or drinker

Exclusion Criteria:

* Patient has atypical Parkinson's syndrome due to drugs, identified metabolic and/or neurologic disorders, encephalitis, or other degenerative syndrome
* Patient has known intolerance or hypersensitivity to levodopa or carbidopa
* Patient has been on anticholinergics or memantine within 30 days prior to dosing
* Patients have a history of the following: seizure disorder, stroke or head trauma, pronounced cognitive impairment, psychiatric disorder, cardiovascular disease, cancer, diabetes as defined by HbA1c of greater than 8%
* Patient has a systolic BP or less than 80 mm Hg or greater than 150 mm Hg
TEMOkids Study : A Phase I Pediatric Study for KIMOZO, Oral Suspension of Temozolomide

Non-randomized, international, multi-centre, open-label, single arm study to determine the pharmacokinetic (PK) parameters of a single dose of an oral suspension of temozolomide (KIMOZO) in the pediatric population aged 1 year and over.

The TEMOkids study is an international open-label, non-randomized, prospective, single-arm phase 1 study to determine the pharmacokinetic (PK) parameters of a single dose of an oral suspension of temozolomide (KIMOZO) in the pediatric population aged 1 year and over.

Patients will be subject to at least one 21 or 28-day treatment cycle involving administration of an oral suspension of temozolomide (KIMOZO) for five consecutive days followed by 16 or 23-days resting period, with determination of the PK parameters on the first treatment day.

Five (5) additional cycles will be allowed under compassionate use regimen. The compassionate use period could be extended at the discretion of the investigator and in agreement with the sponsor. Safety and activity data will be collected during the compassionate follow-up period.

The study will be held in multiple sites spread across Europe.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients in need of temozolomide (all indications with 5-day treatment per 21- or 28-day cycle).
* Male and female patients aged 1 to less than 18 years
* Patients who have signed the informed consent or for which one, both parents or legal guardian (depending on local legislation) have signed the informed consent.
* Patients having records of coverage by a health insurance
* Life expectancy ≥ 3 months
* Adequate haematological function:

  * haemoglobin ≥ 80 g/L (transfusion support authorized)
  * neutrophil count ≥ 1.0 x 10e9 cells/L
  * platelet count ≥ 100 x 10e9 cells/L (without transfusion support)
  * in case of bone marrow involvement: neutrophils ≥ 0.5 x 10e9 cells/L and platelets ≥75 x 10e9 cells/L
* Adequate renal function:

  * Creatine clearance ≥ 60 mL/min.1.73m² according to the Schwartz formula \[1\] or its modified form \[2\]
* Adequate hepatic function:

  * bilirubin ≤1.5 x ULN
  * AST and ALT ≤ 2.5 x ULN (AST, ALT 5xULN in case of liver metastases)
* Lansky Score ≥ 70%

Exclusion Criteria:

* Patients who are co-administrated at day one with sodium valproate as it decreases the clearance of temozolomide
* Patients with (naso)gastric tube administration of temozolomide during first cycle of treatment.
* Patients already enrolled in studies investigating temozolomide or other investigational new drugs.
* A post-menarche female with a positive blood/urine pregnancy test at inclusion.
* Known contraindication or hypersensitivity to temozolomide or any chemically close substance
Comparison Between Erythromycin and Neomycin Treatment of Hepatic Encephalopathy

Comparison between the efficacy of two different antibiotics in patients with overt hepatic encephalopathy. The study is randomized, controlled and double-blinded.


Eligibility Criteria:
Inclusion Criteria:

* Hepatic cirrhosis or portal hypertension
* Hepatic Encephalopathy

Exclusion Criteria:

* Acute liver failure
* Neuropsychiatric diseases
* Inflammatory bowel diseases
* Intestinal obstruction
* Shock
* Renal insufficiency
* Alcoholic hepatitis
* Alcohol abuse
* Antibiotic premedication
A Study of TMC435 in Participants With Genotype 1 Hepatitis C Virus (HCV) Infection

The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2b and ribavirin in chronic genotype 1 hepatitis C virus (HCV)-infected participants who are treatment-naive or treatment-experienced (prior relapser or non-responder to Interferon-based therapy) in Japan.

This is an open-label study (all people involved know the identity of the intervention) to evaluate the efficacy and safety of TMC435 (also referred to as jnj-38733214-aaa) in combination with the standard of care therapy (SoC: peginterferon \[pegIFN\] alfa-2b and ribavirin) in adult, genotype 1 hepatitis C virus (HCV)-infected participants who are treatment-naive (never received treatment for HCV), prior relapsers (relapsed after previous interferon \[IFN\]-based therapy), or non-responders (failed to respond to previous IFN-based therapy) in Japan. The study objective is to evaluate the efficacy, safety, and pharmacokinetics of TMC435. A sufficient number of participants who are treatment-naive, prior relapsers to treatment with IFN-based therapy, and prior non-responders to treatment with IFN-based therapy will be enrolled and assigned to 1 of 3 panels (referred to as treatment groups). Participants who are treatment-naive or prior relapsers to IFN-based therapy will receive 12 weeks of treatment with TMC435 (100 mg) once daily with pegIFN alfa-2b and ribavirin (PR) followed by an additional 12 or 24 weeks of treatment with PR. Participants who are non-responders to IFN-based therapy will receive 12 weeks of treatment with TMC435 (100 mg) once daily with PR followed by an additional 36 weeks of treatment with PR. TMC435 is a 100-mg capsule and will be taken orally by mouth. The SoC treatment will consist of Pegylated interferon (PegIFN alpha-2b) (1.5 mcg/kg) injected with a syringe subcutaneously (under the skin) once weekly and ribavirin 200-mg capsules (daily dose: 600-1000 mg based on body weight) taken orally by mouth 2 times a day after meals for 24 or 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have chronic genotype 1 HCV infection with HCV RNA level \>= 5.0 log10 IU/mL
* Patient has never received treatment for HCV (treatment-naive), relapsed after previous IFN-based therapy (prior relapser) or failed to respond to previous IFN-based therapy (non-responder)
* Patient must be willing to use contraceptive measures from the time of informed consent to 6 months after last dose of study medication.

Exclusion Criteria:

* Co-infection with any other HCV genotype or co-infection with the human immunodeficiency virus (HIV)
* Diagnosed with hepatic cirrhosis or hepatic failure
* A medical condition which is a contraindication to peg-IFN or ribavirin therapy
* History of, or any current medical condition, which could impact the safety of the patient in the study
Health-Related Symptom Questionnaires in Measuring Quality of Life in HIV-Infected Participants Treated or Monitored for Anal Lesions

This research trial studies health-related symptom questionnaires in measuring quality of life in human immunodeficiency virus (HIV)-infected participants treated with or monitored for anal lesions. Collecting information and symptoms from patients diagnosed with anal lesions may help reduce the risk of anal cancer.

PRIMARY OBJECTIVES:

I. To develop an Anal Cancer/HSIL Outcomes Research Study (ANCHOR) high-grade squamous intraepithelial lesion (HSIL) health-related quality of life (HRQoL) Index (HQI) using state-of-the-art measure development methodology that captures the most important HRQoL symptoms and concerns of those persons diagnosed with anal HSIL and either treated or untreated for anal HSIL.

OUTLINE:

Participants complete the ANCHOR HSIL HRQoL interview over 45-60 minutes, comparing the list of symptoms, concerns, or HRQOL impacts related to HSIL diagnosis and treatment. Some patients also complete a cognitive interview for up to 3 sessions.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection
* Biopsy-proven anal HSIL within the prior six months
* Life expectancy of greater than 5 years

Exclusion Criteria:

* History of anal cancer
* Inability to understand a written consent form
Comparison of Airtraq Versus MacIntosh Intubation Via Nasal Approach

Time, success rate, and number of optimising maneuvers for tracheal intubation via the nasal approach are not different when Aitraq technique is used compared to a standard MacIntosh blade.

One hundred adult patients with an expected easy intubation and 100 patients with an expected difficult intubation are enrolled. Intubations are performed by two experienced fully boarded anesthesiologists. The design of the study is prospective and randomised.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for nasal intubation
* Adult

Exclusion Criteria:

* Age under 18 years