cyrilzakka/clinical-trials huggingface dataset:
A Study of Vincristine, Escalating Doses of Irinotecan, Temozolomide and Bevacizumab (Vit-b) in Pediatric and Adolescent Patients With Recurrent or Refractory Solid Tumors of Non-hematopoietic Origin

This phase I study is designed to determine the maximum tolerated dose of Irinotecan given intravenous for 5 days every 3 weeks in combination with fixed doses of Vincristine, Temozolomide and Bevacizumab (VIT-B) in patients with refractory solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Age: Patients must be \> 12 months and \< 21 years of age at the time of study entry.
* Weight: Patient must be more than or equal to 10 Kilograms.

Histological Diagnosis:

* Patients must have had histological verification of the malignancy at some time prior to study entry.
* All solid tumors are eligible with the exclusion of lymphomas. For patients with neuroblastoma, diagnosis based on elevated catecholamines in the urine and tumor cells on bone marrow aspirates/biopsies is acceptable.
* For patients with germ cell tumors, diagnosis based on elevated tumor markers (serum alpha fetoprotein and/or serum beta human chorionic gonadotropin) and radiographic evidence of disease is acceptable.

Disease Status:

* Disease must have failed standard therapy (therapies) or be a disease for which no standard therapy exists.
* Patient with stable disease on other therapies are not eligible.

Performance Level:

* Karnofsky \> 50% for patients \>16 years of age and Lansky \> 50 for children \< 16 years of age (Appendix I).
* Life Expectancy: Must be \> 8 weeks.

Exclusion Criteria:

* Patients who have received bevacizumab and/or Irinotecan previously are ineligible. Non brain tumor patients who have previously received Temozolomide are ineligible.
* Pregnancy or Breast-Feeding: Pregnant patients are ineligible for this study due to the known teratogenic effects of the cytotoxic agents. Pregnancy tests must be obtained in females of childbearing potential prior to enrollment.
* Lactating women must agree not to breast-feed.
* Males or females of reproductive age may not participate unless they have agreed to use an effective contraceptive method.
* Patients Who Have an Uncontrolled Infection will not be eligible for enrollment until all infections are under control.
* Clinically Significant Unrelated Systemic Illness: Patients with serious infections or significant pulmonary, hepatic, renal, or other end-organ dysfunction which in the judgment of the Principal or Co-Investigators would compromise the patient's ability to tolerate prescribed chemotherapy or are likely to interfere with the study procedures or results will not be eligible.
Methylnaltrexone as a Method to Improve Ticagrelor Uptake in Morphine Treated STEMI Patients

This study will examine the impact of the peripheral opioid antagonist methylnaltrexone on the onset of effect of ticagrelor in morphine treated patients with ST elevation myocardial infarction (STEMI). Half of the participants will receive methylnaltrexone, while the other half will receive placebo.

The rate of drug absorption in the gastro-intestinal tract is often determined by the rate of gastric emptying. Morphine treatment, which is frequently given in order to relieve pain in patients with STEMI, is known to delay gastric emptying, and has indeed emerged as a predictor of delayed/poor antiplatelet response in patients receiving oral prasugrel or ticagrelor.

In recent years, morphine has been found to delay the onset of oral P2Y12-inhibitors. To counteract this, the investigators hypothesized that an opioid antagonist may be used. The opioid antagonist naloxone has previously been shown to reduce the morphine induced delay in gastric emptying However, naloxone crosses the blood-brain barrier (BBB) and reduces the pain relieving effects of morphine. In contrast, the morphine antagonist methylnaltrexone has a reduced passage over the BBB and acts primarily as a peripheral morphine antagonist without affecting the morphine-mediated central analgesic effects.

The aim of the planned study is to evaluate whether methylnaltrexone bromide may reduce the morphine induced delay in onset of platelet inhibition after a loading dose of 180 mg ticagrelor in morphine treated patients with STEMI undergoing primary percutaneous coronary intervention (PCI), where a rapid and adequate platelet inhibition after the administration of ticagrelor is crucial. As morphine is an inclusion criterion, all patients included in the study will be on morphine treatment. Thus, morphine treatment is not an intervention to be administered as part of the protocol. Stratification according to inferior and anterior/lateral STEMI will be perform to avoid imbalance in the location of myocardial infarction between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of STEMI
* Administration of a 180 mg loading dose ticagrelor
* Analgesic treatment with intravenous morphine pre-PCI

Exclusion Criteria:

* Cardiac arrest
* Body weight \> 114kg
* Vomiting after intake of ticagrelor loading dose
* Use of Naloxone before inclusion or during sampling period
* Inability to understand study outline and instructions
* Methylnaltrexone bromide contraindication
* Age \<18 years; 8) Women in fertile age
* Administration of ticagrelor during the week before inclusion
* Treatment with Cangrexal
* Ongoing long-term opioid treatment.
The Relationship of Essential Fatty Acids to Adult ADHD: The OCEAN Study (Oils and Cognitive Effects in Adult ADHD Neurodevelopment)

Brief summary

The aim of the study is to provide preliminary data on the relationship of Essential Fatty Acids (EFAs) to cognitive and electrophysiological measures of brain and behavioural functions in adults with attention deficit hyperactivity disorder (ADHD) and controls. This main aim will be achieved in two ways. First the investigators will measure the relationship of the various measures to blood levels of EFAs in ADHD cases and controls. Secondly, the potential effects of dietary supplementation with EFAs on cognitive-electrophysiological and behavioural measures in ADHD cases will be investigated. We will evaluate the extent to which changes in neuronal activity and cognitive performance are related to behavioural and functional measures over time. This is to be carried out by conducting a randomised controlled trial of fish oil supplementation in adults with ADHD (The OCEAN study: Oils and Cognitive Effects in Adult Neurodevelopment).

The study design will be a 6-month double blind placebo control study with a group of 80 adults with a diagnosis of ADHD. The group will be divided into 40 participants who receive EFA dietary supplements and 40 who receive placebo, over a 6-month period. Allocation to EFA dietary supplementation and placebo groups will be randomly allocated and blind to both the investigator and participants. In addition a sample of 30 controls will take part in baseline levels of assessment and be used for case-control comparisons to investigate the links between EFA blood levels and cognitive-electrophysiological function at one time point.

The study design will enable preliminary data to address the following hypotheses:

1. Changes in cognitive and electrophysiological function (neuronal activity) will be found following supplementation with dietary EFAs.
2. Changes in cognition and/or brain activity will be related to blood levels of EFAs.
3. Changes in cognitive performance and electrophysiological parameters will correlate with behavioural function, affective regulation or functional impairments.
4. At baseline, case-control differences in EFA blood-levels will be found which will be linked to cognitive and electrophysiological function.


Eligibility Criteria:
Inclusion Criteria:

* Cases:
* Clinical diagnosis of ADHD (combined or inattentive type)
* Controls:
* Screen below threshold for ADHD

Exclusion Criteria:

* Cases:
* Autism spectrum disorder
* Recurrent major depression
* Bipolar I disorder
* Psychotic disorders
* Obsessive compulsive disorder
* Learning difficulties (IQ \< 80)
* Neurological problems
* Drug abuse
* Those who are already taking EFA supplements
* Metabolic conditions
* Infectious diseases
* Controls:
* ADHD
* All other exclusion criteria for cases as above
Assessment of the Safety and Performance of a Compression Knee Support in the Prevention of Injuries During Sports Practice

Decathlon has developed kneeSOFT100 product which is medical device designed to reduce pain and joint instability during sport practice. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeSOFT100 product to demonstrate safety and performance of this device in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Subject is aged ≥18 years old
* Subject has chronic pain AND / OR chronic knee instability
* The current condition of his/her knee allows the subject to resume usual physical activity
* Subject has been informed and is willing to sign an informed consent form
* Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (6 weeks)
* Subject is affiliated to the French social security regime

Exclusion Criteria:

* Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
* Subject has worn a support (knee brace or articulated orthosis) during sports sessions during the last month
* Subject has any medical condition that could impact the study at investigator's discretion
* Subject has a known hypersensitivity or allergy to the components of the device (elastodiene, polyester)
* Adult subject to a legal protection measure
Social Cognition Dysfunctions in Parkinson's Disease

Parkinson's disease (PD) is usually responsible of cognitive and behavioral non-motor signs with a major impact on the quality of life. Social cognition is a complex system relying on emotion recognition (neurons mirror system (NMS)), the theory of mind (with its two parts: emotional and cognitive), but also on the social and cultural environment and the personal history. The first step in this model is represented by the NMS, which seems to be altered in PD patients for both positive and negative emotions as shown in our preliminary study. The investigator purpose is to investigate the role of the treatment (levodopa and deep brain stimulation) on the functioning of the NMS


Eligibility Criteria:
Inclusion Criteria:

For all participants:

* Man or woman
* Participant not objecting to participation in the study
* Age ≥ 30 and ≤ 70 years old

Specific inclusion criteria for patients:

* Patients with Parkinson's disease with motor fluctuations and dyskinesias receiving deep-brain stimulation
* Patients able to understand the issues of the study

Exclusion Criteria:

For all participants:

* Person deprived of liberty by judicial or administrative decision
* Person subject to a legal protection measure (tutorship, curatorship)
* Person concurrently participating in another research project who may interfere with the results or conclusions of this study

Specific exclusion criteria for healthy volunteers

* Person presenting or having presented a neurological or psychiatric pathology
* Person with a serious medical condition
* Person who has exceeded the annual amount of compensation authorized for participation in research protocols
Treatment of MEDITOXIN® in Female Patients With Idiopathic Overactive Bladder

To investigate the safety of MEDITOXIN in female subjects with idiopathic overactive bladder compared with BOTOX


Eligibility Criteria:
Inclusion Criteria:

* Female aged more than 20 years
* Subject who has symptoms of Overactive Bladder for a period of at least 6 months immediately prior to screening

Exclusion Criteria:

- Patient not appropriate for participating in this study according to the investigator's opinion
Comparison of WHO Treatment of Acute Watery Diarrhea With or Without Probiotic (Bacillus Clausii) in Children

This study aimed to compare WHO treatment of acute watery diarrhea with or without probiotic (bacillus clausii) in term of mean duration of diarrhea in children

Available literature regarding the use of probiotics is not conclusive and contains controversy, and local data is also scarce. Therefore, this study was planned to further explore the use of probiotics to furnish the local data. If significantly less mean duration of diarrhea is noted in the probiotic group, it will help to add probiotic bacillus clausii in routine treatment regimen recommended by WHO and to decrease costs associated with prolonged treatment. However, if otherwise results will be noted it will help to rule out use of probiotic bacillus clausii in children with acute diarrhea to avoid its unnecessary use.

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Aged 6 to 59 months
* Suffering from acute watery diarrhea for ≤ 7 days

Exclusion Criteria:

* Children with blood in stool
* With prior antibiotics use
* Children under study with duration of stay more than 5 days
* clinical signs of a coexisting acute systemic illness like pneumonia, sepsis, meningitis, severely malnourished
* Immunocompromised children
* Hypersensitivity to probiotics
* With prior probiotic administration
Comparison of Glue With Sutures for Pterygium Surgery

Pterygium excision surgery involves excising the abnormal growth from the cornea and filling the defect with a conjunctival (white of the eye) graft from the superior part of the eye. This is the best method of pterygium excision but it is recognised that in 10-15% of cases it will grow back (recurrence). Currently the investigators use small sutures to sew the graft in place. Recently it has been described that glue can be used instead of the sutures. It has been shown in one study that the patient discomfort is less and so is the surgical time. The investigators want to confirm these findings and also compare the recurrence rate between the two types of surgery. They plan to complete a prospective, randomised, control trial of 40 participants. Twenty will have traditional pterygium surgery with the conjunctival autograft sutured. Twenty will have cut and paste surgery with Tisseel glue. The two groups of participants will be compared for pain and discomfort, surgery time, and recurrence rate of the pterygia.

This is a prospective, randomised, control trial of 40 participants. Twenty patients in each arm. Twenty patients undergo standard pterygium excision with the conjunctival autograft sutured. Twenty patients undergo pterygium surgery with Tisseel glue replacing sutures as a method of attaching the conjunctival autograft. Participants will be reviewed, selected, and consented on a pre-assessment day. Surgery will be performed 10 at a time on an all day surgery operating list. Randomisation of the surgery type will be done at the time of surgery after the pterygium has been excised and the autograft taken. One surgeon (R. Hall) will perform all of the procedures. Follow-up will occur at week 1, 2, 4, 26, 52. A questionnaire answered by participants will indicate their pain, foreign body sensation, tearing, and discomfort. There will be observation of any complications such as graft failure and recurrence rate. Photographs will be taken pre-op and post-op.

Eligibility Criteria:
Inclusion Criteria:

* Primary pterygium

Exclusion Criteria:

* Ocular surface disease
* Previous pterygium surgery
A Study of Pharmacodynamics of RO5083945 in Patients With Head and Neck Squamous Cell Carcinoma

This open-label study will assess the pharmacodynamics, safety and efficacy of RO5083945 as compared to cetuximab in patients with head and neck squamous cell carcinoma. Patients will receive at least 2 infusions of either RO5083945 or cetuximab. Anticipated time on study treatment is up to 3 months, and target sample size is \<50.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/=18 years of age
* squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx

Exclusion Criteria:

* carcinoma of nasal cavity, paranasal sinus and nasopharynx
* recurrent squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
* known positivity for HIV, hepatitis B and/or hepatitis C infection
Evaluation of a Probiotic (Bifidobacterium in the Treatment of Infantile Colic (IC)

Infantile colic (IC) criteria includes all of the following in subjects aged ≤ 4 months: paroxysms of irritability, fussing, or crying that start and stop without obvious cause; episodes lasting 3 or more hours per day and occurring at least 3 days per week for at least 1 week; and no failure to thrive. The condition is very common in the first 4 months of life (10-30 % of infants) with a peak prevalence at 6-8 weeks and is characterized by excessive and inconsolable crying without an identifiable cause. Infantile colic cause considerable stress for the baby and the family, huge medical expenses (the IC cause 10-20 % of all pediatric visits in the first 4 months of life) and frequent formula changes.

The pathophysiology of IC is still poorly defined, but differences in gut microbiota composition seem to be involved. In particular, differences in the number and species of Lactobacilli spp, Klebsiella spp and Escherichia coli spp have been demonstrated in subjects with IC, and it has been postulated that these alterations could be responsible for an abnormal gas production within gut lumen resulting in distension and abdominal pain. These findings suggest the potential role of probiotics as preventive and therapeutic strategy for the IC.


Eligibility Criteria:
Inclusion Criteria:

* exclusively breastfed healthy infants of both sex, aged ≤ 7 weeks;
* Diagnosis of IC according to Rome III criteria
* Written informed consent of the parent/tutor

Exclusion Criteria:

* Birth weight\<2500 g
* Gestational age\<37 weeks
* APGAR 5 minutes \<7
* Formula feeding
* Abnormal body growth/loss of weight (\<100 g/weeks from birth to the last reported weight)
* Neurological diseases
* Known or suspected food allergy
* Gastroesophageal reflux disease
* Use of substances that alter gut microbiota (pre/pro/synbiotic, antibiotics, gastric acidity inhibitors) or any anti-colic drug in the last 2 weeks prior the enrollment
* History of fever and/or infectious diseases in the last 2 weeks prior the enrollment
* Ongoing systemic infections
* History of congenital infections
* Chronic intestinal diseases (cystic fibrosis or other forms of pancreatic insufficiency primitive)
* Malformation of the gastrointestinal (such as esophageal atresia, intestinal atresia, short bowel syndrome, malrotation), urinary or respiratory tract
* Metabolic diseases
* Genetic diseases and chromosomal abnormalities
* Primary or secondary immunodeficiencies
* Not sufficient reliability or presence of conditions that may result in non-compliance/adherence of the patient to the Protocol
* Previous participation in this study
A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)

This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.


Eligibility Criteria:
Inclusion Criteria:

* Have a Major Depressive Disorder (MDD) primary diagnosis
* Have a body mass index (BMI) of 18.0 to \</= 40.0 kg/m\^2
* Be willing and able to follow the study procedures and visits as outlined in the protocol (including agreeing not to enroll in any other clinical trials)
* Have inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
* Additional criteria may apply

Exclusion Criteria:

* Has any finding that would compromise the safety of the subject or affect their ability to adhere to the protocol visit schedule or fulfill visit requirements
* Has any other significant medical condition (eg, neurological, psychiatric, or metabolic) or clinical symptom that could unduly risk the subject or affect the interpretation of study data
* Has any current primary diagnosis other than MDD, where primary diagnosis is defined as the primary source of current distress and functional impairment
* Has experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
* Has been hospitalized for MDD within 3 months before screening
* Has used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days prior to screening
* Has received electroconvulsive therapy treatment within the last 2 years or within the current MDE or failed a course of electroconvulsive treatment at any time
* Has a significant risk for suicide
* Has a positive breath alcohol test at screening
* Has a positive test for drugs of abuse at screening or visit 2
* Is pregnant, planning to become pregnant, or is breastfeeding during the study
* Additional criteria may apply
A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease

This is a multicenter, randomized, three-arm, parallel-group, double-blind, placebo-controlled, study to evaluate the efficacy, safety and pharmacokinetics (PK) of pridopidine vs. placebo for the treatment of Levodopa Induced Dyskinesia (LID) in patients with Parkinson Disease.


Eligibility Criteria:
Inclusion Criteria:

* Provides signed informed consent form.
* Has clinical diagnosis of Parkinson's Disease (PD).
* Has Levodopa-induced dyskinesia (LID).
* Patient and/or study partner must demonstrate ability to keep accurate home diary of PD symptoms.
* Has stable anti-PD treatments for at least 28 days prior to start of study treatment and kept constant throughout study.
* All routine and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must be at stable dosage for at least 28 days prior to start of study treatment and maintained throughout study.

Exclusion Criteria:

* Diagnosis of atypical Parkinsonism.
* Treatment with dopamine blocking drugs.
* History of surgical intervention related to PD, such as deep brain stimulation.
* History of severe depression, psychosis or hallucinations within 6 months prior to screening; active suicidal ideation; or suicidal attempt within 5 years prior to screening.
* History of certain cancers within 5 years prior to screening.
* Significant cardiac event within 12 weeks prior to Baseline or history of certain cardiac arrhythmias.
* History of epilepsy or seizures within 5 years prior to screening.
* Females who are pregnant or breastfeeding.
* Sexually active female patients who are not surgically sterile or at least 2 years postmenopausal prior to screening, and who do not agree to utilize a highly effective hormonal method of contraception in combination with a barrier method, from screening until at least 4 weeks after completion of study treatment.
* Male patients not using highly effective contraception or not agreeing to continue highly effective contraception until at least 90 days after the completion of study treatment.
* Treatment with any investigational product within 30 days of screening or plans to participate in another clinical study assessing any investigational product during the study.

Other protocol-defined inclusion/exclusion criteria could apply.