cyrilzakka/clinical-trials huggingface dataset:
Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)

To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have undergone surgical resection or local ablation (PEI or percutaneous or intraoperative RFA) for treatment of HCC with curative intent within 4 months from staging to potentially curative treatment. A maximum of 2 local ablation courses may be administered during this time period.
* At least 3 weeks (21 days) but no more than 7 weeks (49 days), from resection or last local ablation course, to CT/MRI scan date
* Male or female subjects \>/= 18 years of age
* Confirmation of CR (absence of residual tumor after curative treatment), on the eligibility scan by independent radiological review.
* For subjects undergoing surgical resection pathology proven complete removal of tumor.
* Intermediate or High Risk of recurrence as assessed by tumor characteristics.
* Child-Pugh score 5 -7 points. A Child-Pugh score of 7 points is allowed only in the absence of ascites.
* ECOG Performance Status of 0.
* Adequate bone marrow, liver and renal function

Exclusion Criteria:

* Recurrent HCC
* Child-Pugh score 7 points with presence of ascites.
* Low risk of recurrence after curative treatment
* History of cardiovascular disease
* History of HIV infection
* Active clinically serious infections (\> grade 2 NCI-CTCAE version 3.0)
* Subjects with seizure disorder requiring medication (such as steroids or anti-epileptics)
* Subjects with evidence or history of bleeding diathesis
* Subjects undergoing renal dialysis
* Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors \[Ta, Tis \& T1\] or any cancer curatively treated \> 3 years prior to study entry as defined by the signing of informed consent..
* Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
* Encephalopathy
* History of GI bleeding within 30 days of randomization.
* Subjects with a history of esophageal varices bleeding which has not been followed by effective therapy and/or treatment to prevent bleeding recurrence.
* Prior anti cancer therapy for treatment of HCC (including sorafenib or any other molecular therapy) is excluded.
* Major surgery within 4 weeks of start of study as defined by the signing of informed consent, except for surgical resection or local ablation of HCC.
* Investigational drug therapy outside of this trial during or within 4 weeks of study entry, as defined by the signing of informed consent.
* Liver transplantation, this includes patients on a transplant list with the intention to transplant
Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma

This is a phase 2 study to evaluate the efficacy of single-agent erlotinib versus oral etoposide in patients with recurrent or refractory pediatric ependymoma.

This is a phase 2 study involving a 1:1 randomization of 40 patients with recurrent or refractory pediatric ependymoma who will receive either erlotinib or oral etoposide.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent of refractory ependymoma or subependymoma
* Performance Status (PS): Lansky ≥ 50% for patients ≤ 10 years of age or Karnofsky ≥ 50% for patients \>10 years of age
* Measurable disease, defined as 1 measurable lesion that can be accurately measured in 2 planes that has not received radiation therapy within 12 weeks
* Recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
* ≥ 1 year to ≤ 21 years
* Serum creatinine for patients ≤ 5 years in age is ≤ 0.8 mg/dL or Creatinine Clearance/Glomerular Filtration Rate (GFR) ≥ 70 mL/min/m\^2
* Serum creatinine for patients \> 5 and ≤ 10 years in age is ≤ 1.0 mg/dL or Creatinine Clearance/GFR ≥ 70 mL/min/m\^2
* Serum creatinine for patients \> 10 and ≤ 15 years in age is ≤ 1.2 mg/dL or Creatinine Clearance/GFR ≥ 70 mL/min/m\^2
* Serum creatinine for patients \> 15 years in age is ≤ 1.5 mg/dL or Creatinine Clearance/GFR ≥ 70 mL/min/m\^2
* Total bilirubin is ≤ 1.5 x upper limit of normal for age
* Alanine aminotransferase (ALT) ≤ 3 x upper limit of normal
* Absolute neutrophil count \> 1000/µL
* Platelet count \> 100,000/µL
* Hemoglobin \> 8 gm/dL
* Neurologically stable for at least 7 days prior to randomization
* If receiving corticosteroids, patients must be on a stable or decreasing dose for at least 7 days before randomization
* Patients of reproductive potential must agree to proactive effective contraceptive measures for the duration of the study and for at least 90 days after completion of study drug

Exclusion Criteria:

* Previously received epidermal growth factor receptor (EGFR)-targeted therapy
* Previously received oral etoposide
* Received craniospinal radiotherapy within 24 weeks prior to randomization
* Received field radiotherapy to the target lesion within 12 weeks prior to randomization
* Received symptomatic metastatic disease within 14 days prior to randomization
* Received myelosuppressive chemotherapy within 21 days before randomization
* Received growth factors within 7 days prior to randomization
* Participating in another investigational drug trial
* Received a biologic agent within 7 days prior to randomization
* Received a monoclonal antibody within 28 days prior to randomization
* Taking cytochrome P450 (CYP)3A4 or CYP1A2 inhibitors/inducers within 14 days prior to randomization
* Taking proton pump inhibitors within 14 days prior to randomization
* Smoking during treatment
* Pregnant or breast-feeding females
Efficacy Study of Vx001 Vaccine in NSCLC Patients

Patients with stage IV or recurrent stage I-III NSCLC with documented disease control (objective response or stable disease) within 3 weeks after platinum based 1st line chemotherapy; only HLA-A\*0201 positive patients with TERT expressing tumors will be included.

The objective of the trial is survival rate at 12 months.


Eligibility Criteria:
Main Inclusion Criteria:

1. Male or female ≥18 years of age;
2. Documented stage IV NSCLC as defined by IASLC Lung Cancer Staging Project (7th edition) or recurrent stage I-III disease at least 6 months after resection or after the end of adjuvant chemotherapy or after standard locoregional treatment as defined by the American College of Chest Physicians;
3. Patients treated with 4 cycles platinum based 1st line chemotherapy as defined by the American College of Chest Physicians (i.e. radiotherapy are not allowed except palliative radiotherapy of bone metastasis);
4. Documented HLA-A\*0201 positivity, as determined by a local laboratory;
5. TERT-positive NSCLC, as assessed by a central laboratory; for this, availability of adequate tissue biopsy from the primary tumor, lymph nodes or distant metastases is a prerequisite;
6. CR, PR, or SD according to RECIST 1.1 criteria after the completion of platinum-based first-line chemotherapy;
7. ECOG performance status 0, 1;

Main Exclusion Criteria:

1. Mixed small cell and NSCLC histologies;
2. Patients with stage IV or recurrent NSCLC who have been previously treated with therapy other than platinum-based first-line chemotherapy;
3. Prior treatment with cancer vaccines;
4. Prior treatment with immunotherapy (e.g., interferons, interleukins, TNF, or biological response modifiers, such as GM-CSF etc) within four weeks prior to randomization;
5. Prior treatment with hormone (including corticosteroids) within 2 weeks prior to randomization;
6. Prior treatment with any investigational drugs, within 4 weeks prior to randomization;
7. Patients with brain metastases;
A Center Based Study of Pivotal Response Treatment for Preschoolers with Autism

The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based environment to treat social communication deficits in children with autism spectrum disorder (ASD).

The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based preschool environment to treat social communication deficits in children with autism spectrum disorder (ASD). The study will compare Pivotal Response Treatment (PRT) to a delayed treatment group (DTG). PRT is a naturalistic behavioral intervention based on the principles of applied behavior analysis which has shown to be effective in treating the core deficits in children with ASD. The study will compare the combination of parent training with intensive center-based PRT (PRT-C) to a DTG and will include 44 children ages 2 to 3.11 years with ASD and social communication deficits.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Autism Spectrum Disorder (ASD) based on clinical interview and Diagnostic and Statistical Manual, 5th edition (DSM-5) and confirmed using the Autism Diagnostic Interview Revised (ADI-R) and Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) or Childhood Autism Rating Scale (CARS-2); Diagnostic and Statistical Manual, 5th edition (DSM-5), and expert clinical opinion
* Boys and girls between 2 years and 3 years and 11 months
* Ability to participate in the testing procedures to the extent that valid standard scores can be obtained
* Stable treatment (e.g., applied behavior analysis (ABA), speech therapy, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation
* Developmentally delayed with Mullen Scales of Early Learning (MSEL) or Developmental Profile (DP-4) composite score below 85 (1 Standard Deviation below the mean)
* Availability of at least one English-speaking parent who can consistently participate in parent training and research measures.

Exclusion Criteria:

* Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.)
* Presence of active medical problem (e.g., unstable seizure disorder or heart disease)
* Child primary language other than English
* Previous adequate trial of Pivotal Response Treatment
* More than 15 hours per week of in-home applied behavior analysis (ABA).
Forest Bathing Intervention for Persons Living with Dementia and Family Carers

This study assessed the feasibility and acceptability of a forest bathing intervention for people living with dementia and their family carers, and examined its effectivness on care burden and quality of life by comparing to an art activty programme as control group.


Eligibility Criteria:
Inclusion Criteria:

* For family careivers:
* taking care of a family member living with dementia in the community,
* For people living with dementia:
* Clinical diagnosis of mild to moderate dementia

Exclusion Criteria:

* For both:
* Unable to communicate in Chinese or Cantonese
* Unable to participate meaningfully in group activities due to intellectual disability, visual impairment, hearing impairment, or other health conditions, were excluded.
Phase 1 Study to Determine the Effects of PBT2 on the Pharmacokinetic Profile of Caffeine

This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of caffeine and the effects that PBT2 has on the metabolism of caffeine in healthy volunteers.

This study will be conducted with all participants receiving a dose of caffeine 100 mg on Day 1 followed by a 7 day washout period before commencing 5 consecutive days of PBT2 250 mg from Day 8 to 12 and a second dose of caffeine 100 mg on Day 12. Pharmacokinetic samples will be collected during after each dose of the study drugs, along with safety monitoring assessments.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females with a BMI between 19 and 30kg/m2
* No clinically significant abnormalities

Exclusion Criteria:

* Exposure to medications/drugs that interfere with metabolism of PBT2 including drugs that inhibit or induce CYP1A2
* Use of caffeine-containing beverages, supplements or alcohol
* Significant history of depression or other psychiatric illness
* Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion
* Unable to swallow capsules or tablets
Early Application of CPAP in Hematologic

The purpose of this study is to evaluate the use of CPAP in the prevention of acute respiratory failure in neutropenic ( or hematologic malignancy ) patients .CPAP applied preventively in hematological patients with high risk of ARF may reduce:need for intubations and mechanical ventilation, incidence of pneumonia and sepsis,mortality,length of ICU and hospital stay

Immunocompromised patients with a hematological malignancy that requiring admission in intensive care unit (ICU) and subsequently mechanical ventilation for respiratory failure was estimated between 20- 50 per cent of all admitted in hospital.

The survival rate of this patients that requiring mechanical ventilation is very poor.

In many cases the immunodepression with a great improvement in severe complication as infections , pneumonia, sepsis , is the consequence of our therapy ( chemotherapy , bone marrow transplantation and stem cell transplantation ) .

Pneumonia is very common cause of mechanical ventilation in about 45-74 per cent of the all patient with acute respiratory failure (ARF) .

The trial was designed to enroll 40 patients in two groups to demonstrate reduction from 50% to 10 % of the need of mechanical ventilation , with a type I risk of error of 5% and a power of 80 %.

Patients were randomized to be treated for four days Venturi mask at a FiO2 of 0.4 (control) or with oxygen at a FiO2 of 0.4 plus a CPAP of 10 cm H2O (CPAP). At the end of the 4-days period, patients passed a screening test breathing ambient air. Patients returned to the assigned treatment if SaO2 less than 95% a.a or respiratory rate more than 25 bpm.CPAP was generated using a flow generator with an adjustable inspiratory oxygen fraction set to deliver a flow of up to 140 liters per minute (Whisperflow, Caradyne, Ireland) and a spring-loaded expiratory pressure valve (Vital Signs Inc, Totoma NJ) and applied using a latex-free polyvinyl chloride transparent helmet (CaStar, Starmed, Italy) (15); all centers measured the inspiratory oxygen fraction using an oxygen analyzer (Oxicheck, Caradyne, Ireland) through the Venturi mask or the helmet.

Eligibility Criteria:
Inclusion Criteria:

* Neutropenic hematological patients ( less than 1000 leukocytes /mm3 ) .
* SaO2 less than 95% ( a.a.) ,
* Respiratory rate (RR ) more than 25 breaths/minute .

Exclusion Criteria:

* NYHA class II- III- IV or unstable angina or MI
* Valvular heart disease or cardiac surgery ( previous 3 months)
* Implanted cardiac pacemaker
* BMI less than 40
* History of dilated cardiomyopathy or CPE
* Severe COPD ( oxygen therapy , recent exacerbation, hypoxemic-hypercapnic to resting , FEV1 \< 50 %)
* Diagnosis of sleep or neuromuscular disorders.
* Claustrophobia .
* Mechanical ventilation criteria:

  * Severe hypoxemia (arterial oxygen saturation \< 80 % with maximal FiO2 )
  * Ph \< 7.3 with a PaCO2 \> 50 mmHg
  * Signs of patient distress with accessory muscle recruitment and paradoxal abdomen movement
  * RR \> 35 breaths/minute .
The Glycaemic and Insulinaemic Responses of Camel Milk

Rationale: Recently, human, animal and epidemiological studies suggested that camel milk has a hypoglycaemic activity. However, a mechanism and reasons for this activity have not been sufficiently studied. Therefore, a study on a glycaemic and insulinaemic responses of regular camel milk and camel milk powder is needed.

Objective: To explore the glycaemic and insulinaemic responses of regular camel milk and camel milk powder in healthy adults.

Study design: In a randomised, single-blind and cross over design, two hour post prandial glucose and insulin responses of 4 treatments (regular camel milk, camel milk powder, regular cow milk and glucose) will be measured . Those treatments will be consumed in a portion that contained 25g available carbohydrate. Finger-prick capillary blood samples will be taken at fasting, and 15, 30, 45, 60, 90, 120 minutes after ingestion of the test product. Venepunctures will be taken at fasting, 30 and 75 minutes after ingestion of the test product. The measurements will be conducted on 4 separate days with at least 2 days wash out.

Study population: 20 healthy volunteers aged 18 to 35 years, with BMI between 18.5 to 25 kg/m2.

Intervention: The treatments are regular camel milk, camel milk powder, regular cow milk and glucose. These are standardized to 600ml containing 25g available carbohydrate.

Main study parameters/endpoints: Main parameters are postprandial blood glucose and insulin responses. Secondary parameters: amino acid composition and glycemic index.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This intervention is non-therapeutic to the subjects. The risk associated with participation is negligible and the burden can be considered low. Before subjects are able to participate in this study they will have to fill out a brief questionnaire, and have their fasting blood glucose measured, in order to ensure they fit the inclusion criteria of the study. Once entering the study, each subject will have to visit the research centre 4 times for the postprandial tests. On each measurement day, each subject will be required to have fasted for at least ten hours before (an overnight fast). Each subject will have 7 finger-prick blood samples and 3 venapunctures taken during each visit. A maximum amount of 50 ml blood is drawn per day.

There is no detailed description

Eligibility Criteria:
Inclusion Criteria:

* Healthy: as judged by the subjects;
* Age: 18 to 35.

Exclusion Criteria:

* Pregnant or lactating females;
* Presence of a chronic disease such as diabetes, illness, dysmetabolic syndrome;
* 18.5 \> BMI \> 25 kg/m2;
* Lactose intolerance or experiencing discomfort after milk consumption;
* Weight loss or gain of more than 5 kg in the last two months;
* Using an energy restricted diet during the last 2 months;
* Fasting blood glucose levels \>100 mg/dl or 5.6 mmol/l (18);
* Smokers;
* Use of medications other than birth control, paracetamol, aspirin, asthma or hay fever;
* Previous problems with blood sampling.
Pack Cross Linking for Infectious Keratitis

The primary aim of this study is to investigate the efficiency of PACK_ CXL in treatment of infectious keratitis and analyze postoperative outcomes.


Eligibility Criteria:
Inclusion Criteria:

* are age ≥18 years, fungal, bacterial or mixed infectious keratitis, ulcer ≤ 4 mm in diameter and showing a maximum depth of 350 μm (as assessed by either optical coherence tomography (OCT))

Exclusion Criteria:

* age ≤18 years, viral infectious keratitis, non-infectiouskeratitis, melting corneal ulcers with impending perforation, corneal thickness \< 400 μm (including the corneal epithelium) and systemic diseases or systemic surgery, single-eyed and immunosuppressed patients.
Diagnosis of Short Stature in Children : Study of a Cohort of Small-sized Consulting Patients

Many patients consult in pediatric endocrinology because of their small size. In the majority of cases, this growth delays can be explained by a hormonal, gastroenterological cause, or a chronic disease.

Sometimes the reason for stunted growth can be constitutional bone disease, a genetic cause of short stature that is still underdiagnosed.

The investigators wish to describe and take stock of the various additional analyzes carried out and the various diagnoses made in patients who consulted in endocrino-pediatrics at the Montpellier University Hospital due to their short stature, in 2017 and 2018, in order to better screen patients with constitutional bone disease


Eligibility Criteria:
Inclusion criteria:

All the children who consulted for the first time because of their short stature, in pediatric endocrinology at the Montpellier University Hospital between January 2017 and December 2018

Exclusion criteria:

Patient already undergoing specialized medical follow-up due to his small size Major patient
Nutritional Status and Body Composition in Childhood Inflammatory Bowel Disease

Malnutrition and growth retardation are common in children with inflammatory bowel disease (IBD), especially in Crohn's Disease (CD). Malnutrition is associated with disease type, anatomical location, severity of disease and age of patient. Recently, it is reported that almost all children with CD and half with Ulcerative Colitis (UC) have reduced lean mass, however, body fat alteration are not well defined.

The aim of this prospective and observational study was to evaluate nutritional and growth status and body composition of children with IBD using anthropometric measurement and bioelectrical impedance during 1 year follow-up.

Patients 6 to 18 years of age at the time of enrolment who have IBD at any stage of disease activity, on any or no treatment and age- and sex-matched healthy controls will be included. All participants will be followed for 1 year.

Written informed consent will be obtained from the parents or guardians of the participants at the time of enrolment. Prospective and retrospective data will be collected. Complete family and medical history, physical examination and laboratory findings will be recorded on standard case report form. Disease activity will be scored using the Paediatric Crohn's Disease Activity Index for children with CD and the Pediatric Ulcerative Colitis Activity index for those with UC. Endoscopic data will be reviewed and disease location will be classified according to Paris classification. Puberty will be assessed based on the development of secondary sexual characteristics. At the time of enrollment and after 1 year, anthropometric measurements including height, weight, triceps skin fold thickness, middle arm circumference and assessment of body composition by bioelectrical impedance will be performed for each child. Anthropometric data will be standardized by generation of z-scores for height and weight based on age and gender. Growth deficiency for height and weight measurements will be defined as a z-score\\-2.

Eligibility Criteria:
Inclusion Criteria:

* A male or female of 6 to 18 years of age at the time of enrolment
* For children with IBD; the diagnosis of IBD are based on the combination of clinical features and serological, endoscopic, colonoscopic, and histological findings
* For controls : no evidence of inflammatory or chronic disease

Exclusion Criteria:

* A male or female \< 6 years or \> 18 years old at the enrollment

  * For children with IBD : Presence of other chronic diseases
  * For healthy control: Any coexisting chronic disease known to affect growth, nutritional status, dietary intake, or development