cyrilzakka/clinical-trials huggingface dataset:
Nimotuzumab in Combined With Chemoradiotherapy to Treat the Newly Diagnosed Diffuse Intrinsic Pontine Glioma in Children

This is a prospective, open-label, single arm, multicenter clinical study. The purpose of the study is to evaluate the clinical efficacy and safety of combination Nimotuzumab with concurrent radiochemotherapy in children with newly diagnosed diffuse intrinsic pontine glioma(DIPG).

This clinical study is designed as a prospective, open-label, single arm, multicenter study to evaluate the clinical efficacy and safety of combination Nimotuzumab with concurrent radiochemotherapy in children with newly diagnosed diffuse intrinsic pontine glioma(DIPG). The main endpoint is objective response rate, 1-year overall survival rate is also observed.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntary and sign a consent form;
2. Age 3-15 years old, gender unlimited;
3. Histology or imaging diagnosed as diffuse intrinsic pontine glioma, patients haven't received any anti-tumor treatment;
4. According to the RANO criteria, at least one measurable lesion;
5. Before enrollment, the results of laboratory examination are in accordance with:

   Blood routine test: platelet count ≥ 100 × 10\^9/L; absolute neutrophil count ≥ 1.5 × 10\^9/L or leukocyte count ≥ 3.0 × 10\^9/L; hemoglobin ≥ 90g/L; Blood biochemistry: aspartate aminotransferase#AST# ≤ 3 ×Upper Limit Of Normal#ULN#; alanine aminotransferase#ALT# ≤ 3 × ULN; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN;
6. Lansky score ≥ 60;
7. Expected survival time ≥ 3 months;
8. Fertile subjects are willing to take contraceptive measures during the study period.

Exclusion Criteria:

1. Recurrent DIPG;
2. Have received any other anti-tumor treatment for DIPG, including surgical treatment (except biopsy), chemotherapy, radiotherapy, targeted drugs, immunotherapy, etc;
3. Uncontrollable infection, epilepsy and / or hypertension and / or hyperglycemia;
4. Human immunodeficiency virus #HIV# infection or active hepatitis B infection or hepatitis C infection;
5. Active hemorrhage found by CT or MRI before inclusion and / or inability to carry out CT and MRI examination;
6. Major operation (except biopsy) were performed within four weeks before inclusion;
7. Decompensated heart failure (NYHA grades III and IV), unstable angina, acute myocardial infarction, persistent and clinically significant arrhythmia within three months of inclusion;
8. Have other malignant tumor history;
9. Known allergy to Nimotuzumab, temozolomide or its analogues or any component of the prescription;
10. Unable to tolerate radiotherapy;
11. Other reasons that are not suitable to participate in this study according to the researcher's judgment.
Presepsin as Detective Marker of Sepsis in Immunodeficiency ICU Patients

This is an observational study to evaluate the diagnostic and prognostic value of presepsin in the critically-ill immunocompromise patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 19 years
* Appropriate clinical data to enable classification into sepsis
* Written informed consent by the patient or legally authorized representative
* Critical illness consistent with sepsis, to be enrolled within 24 hours of presentation

Exclusion Criteria:

* No informed consent
* A patient who is judged to be unable to make a voluntary decision by understanding information about this research due to cognitive vulnerability
Impact of Pulmonary Rehabilitation After Lung Resection for Cancer on Patients' Level of Anxiety and Depression

The interest of pulmonary rehabilitation for patients who underwent lung resection for cancer remains controversial. The investigators studied the effects of the RR and its impact on quality of life and level of anxiety and depression in patients.

In 2011 and 2012 , an RR was proposed to the patients referred to our center after lung resection for cancer. Patients were assessed at entry and departure by 6minutes walk test , a visual analog pain scale , a quality of life questionnaire ( EORTC QLQ C30 ) and an anxiety questionnaire and Depression (HAD) . These same questionnaires were mailed 6 months after the end of the pulmonary rehabilitation .


Eligibility Criteria:
Inclusion Criteria:

* Patient with pulmonary resection
* Patients undergoing a standardized approach (or thoratomie videothoracoscopy)
Enhancing Fitness Before Pancreatic Surgery

This is a pilot study to investigate the effect of prehabilitation on patients undergoing elective surgery for pancreatic disease.

Pancreatic surgery is high risk. The injury associated with surgery causes a stress response, comprising a variety of hormonal and metabolic effects. Patients undergoing pancreatic surgery experience one of the largest stress responses. Prehabilitation is the process of enhancing an individual's fitness, thereby improving tolerance to an upcoming physiological stress such as surgery. Studies involving prehabilitation have been shown to improve recovery after surgery and reduce complication rates. There are currently no published reports of prehabilitation involving patients undergoing pancreatic surgery. This research study will explore the effect of prehabilitation in these patients.

Patients with pancreatic disease are some of the least fit surgical candidates due to the disease process. Exercise training can improve physical fitness before elective abdominal surgery and nutritional supplementation can also influence clinical course via different mechanisms. Patients with pancreatic disease are often malnourished for several reasons. We propose a multimodal approach to prehabilitation involving dietary and exercise interventions during a four-week period preceding elective surgery. Core data will be collected from cardiopulmonary exercise tests and blood tests (to assess insulin sensitivity), before and after prehabilitation. Secondary outcomes such as length of stay and complications will also be measured postoperatively.

Eligibility Criteria:
Inclusion Criteria:

Elective pancreatic resection

Exclusion Criteria:

Contraindication to cardiopulmonary exercise testing: unstable cardiac disease, lower limb dysfunction Emergency surgery Ischaemic ECG during cardiopulmonary exercise test Allergy to fish oil or olive oil
A Safety Study of 188-0551 Spray Versus Reference Listed Drug (RLD) in Adult Subjects With Plaque Psoriasis

Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is to determine and compare the adrenal suppression potential and the pharmacokinetic (PK) properties of 188-0551 Spray versus an FDA-approved drug (also known as a "Reference Listed Drug" \[RLD\]) under maximal use conditions when applied twice daily (approximately every 12 hours) in adult subjects with stable, moderate to severe, plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a male or non-pregnant female and is at least 18 years of age at the time of informed consent.
* Subject has provided written informed consent.
* Subject has moderate or severe psoriasis involving a minimum of 20% Body Surface Area (BSA).
* Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.

Exclusion Criteria:

* Subject is pregnant, lactating, or is planning to become pregnant during the study.
* Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
* Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, adrenal axis function or which exposes the subject to an unacceptable risk by study participation.
* Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation.
* Subject is currently enrolled in an investigational drug or device study.
* Subject has clinically significant abnormal labs at Visit 1/Screening that precludes topical steroid use, in the opinion of the investigator.
Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer

The 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of advanced breast cancer based on a large pivotal study. However, mono and combination chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially in the palliative setting. The present trial examines the efficacy and safety of weekly paclitaxel over a limited duration combined with continued trastuzumab in HER2+ patients.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed metastatic breast cancer overexpressing HER2
* pretreatment with anthracycline in either the adjuvant or palliative setting.
* HER2 positivity was defined as 2+ or 3+ overexpression using the DAKO HercepTest, confirmed by fluorescence in-situ hybridization (FISH) if 2+.
* informed consent

Exclusion Criteria:

* more than 1 chemotherapy for advanced disease
* taxane or trastuzumab pretreatment
* brain metastases
* Eastern Cooperative Oncology Group (ECOG) performance status \>1
* pregnancy or lactation, childbearing potential without reliable contraception
* clinically significant cardiac disease,
* neutrophils \<1500/µl, platelets \<75,000/µl
* total bilirubin and creatinine \>1.5 × the upper limit of normal
Study to Document the Effectiveness of Dysport in Patients Suffering From Upper Limb Spasticity (ULS) After Stroke

The objective of this non-interventional study is to evaluate clinical effectiveness and cost effectiveness of Dysport within the reimbursement scheme called "drug programme" funded by Polish National Health Fund (NHF) for patients with post stroke ULS. The study is designed to collect data in patients scheduled to receive Dysport treatment in a drug programme, based on routine treatment of subject with ULS.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age.
* A history of ischemic or haemorrhagic stroke before minimum 3 months prior to the inclusion into drug programme, documented by discharge from the hospital.
* Post-stroke spasticity of confirmed upper extremity moderate or higher (the result of the modified Ashworth scale - MAS ≥ 2) in at least one muscle group.
* Classification of the patient into the programme occurs when a patient has a designated date of commencement of medical rehabilitation confirmed by the providing rehabilitation services.
* Drug administration needs to take place no earlier than three weeks before the start of medical rehabilitation.
* Written informed consent given by patient before any occurrence of study related procedure.
* Patient has been already included in a NHF Dysport programme.

Exclusion Criteria:

* Severe dysphagia and respiratory disorders.
* Pregnancy
* Myasthenia gravis and myasthenic syndrome - based on neurological examination (additional tests only in justified cases).
* Generalized symptoms of infection
* The presence of inflammation within the planned sites of administration.
* Fixed contractures in the soft tissues and joints.
* Dementia medium or deep cycle (score on mini mental state examination (MMSE) equal to or less than 18 points).
Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG)

This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.

This is a phase 2 pragmatic study at a single site that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary endpoint is disease control at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy. Participants will receive ablative local therapy per standard practices in addition to their systemic therapy and will be followed for up to 5 years following ablative local therapy. Participants will be assigned stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy per the discretion of treating radiation oncologist and/or interventional radiologist.

Eligibility Criteria:
Inclusion Criteria:

1. Must have one of the following histologically and/or biochemically confirmed cancers:

   1. Cohort A: Esophageal, Gastroesophageal Junction, Gastric
   2. Cohort B: Small bowel
   3. Cohort C: Colorectal and appendiceal
   4. Cohort D: Biliary including gallbladder, intrahepatic and extrahepatic cholangiocarcinoma
   5. Cohort E: Hepatocellular carcinoma
   6. Cohort F: Pancreatic and ampullary
2. Provision of signed and dated informed consent form.
3. Stated willingness to comply with all study procedures and availability for the duration of the study.
4. Age ≥18 years at time of consent.
5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.
6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\]
7. ≤ 5 progressing or new metastatic lesions.
8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist.

Exclusion Criteria:

1. Medical comorbidities precluding locally ablative therapies.
2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
3. Progressing intracranial lesions.
Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma

This study will investigate the safety and tolerability of indacaterol maleate/mometasone furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate asthma.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adult patients aged 18-65 years (inclusive)
* Patients with mild-moderate asthma
* Forced expiratory volume in one second (FEV1) at Visits 1 and 2 are ≥60% of the predicted normal value for the patient.
* Body mass index (BMI) must be within the range of 18-32 kg/m\^2.
* Non-smokers or light smokers (≤10 cigarettes per day), with a smoking history of 10 pack years or less.

Exclusion Criteria:

* Patients who suffer from chronic obstructive pulmonary disease (COPD)
* Patients who have been hospitalized or had emergency treatment for an asthma attack in the 6 months prior to study start
* QTcF interval \> 450 msec in men and \>470 msec in women
* Pregnant women or nursing mothers
* Females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable).
* History of immunocompromise, including a positive human immunodeficiency virus (HIV)
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* History of drug or alcohol abuse within 12 months of dosing

Other protocol-defined inclusion/exclusion criteria may apply.
Oral Morphine Versus Ibuprofen

Children 5-17 years of age who have sustained a non-operative distal forearm (radius and/or ulna) or clavicular fracture will be randomized to receive either ibuprofen or oral morphine as needed for pain relief for the first 24 hours following discharge from the emergency department. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral morphine will result in greater pain relief than ibuprofen.


Eligibility Criteria:
Exclusion Criteria:

* patients with known hypersensitivity to either ibuprofen or morphine
* chronic users of NSAIDS or opioids
* fractures requiring operative management
* associated injuries requiring analgesia
* poor English fluency
* pregnancy

Inclusion Criteria:

* All patients aged 5 to 17 years with a non-operative forearm or distal radius fracture
Non Invasive Ventilation and Weaning : VENISE Trial

The clinical efficacy of noninvasive ventilation (NIV) has now been demonstrated in the management of acute-on-chronic respiratory failure (ACRF) of various etiologies. Endotracheal mechanical ventilation (ETMV) can lead to numerous complications and weaning difficulties increasing the risk of prolonged ETMV, morbidity and mortality as well as excess cost of intensive care. Therefore, it could be interesting to use NIV for delivering effective ventilatory support and reduce the length of ETMV in ACRF patients still not capable to maintain spontaneous breathing. From the interesting but discordant results of two recent randomised controlled trial, a working group from the Société de Réanimation de Langue Française (SRLF) decided to perform a new prospective randomised controlled and multicenter trial. The aim of the study is to assess the usefulness of NIV as an extubation and weaning technique in ventilated ACRF patients. The methodology used compares three weaning strategies in parallel in ACRF patients considered difficult to wean : invasive conventional weaning (group A), extubation relayed by nasal oxygentherapy (group B), and extubation relayed by NIV (group C). Based on the main end-point defined as the weaning success/failure rate, 208 patients from17 investigator centers are planned to be included. Results of the study will also allow to assess the respective impact of the three weaning strategies on the length of ETMV and weaning, the mechanical ventilation-related morbidity, the patients lengths of stay and mortality.

Results of the VENISE trial should permit to improve the management of the difficult to wean ACRF patients and thus to contribute to more define the place of NIV among the weaning and prevention of re-intubation strategies in these patients.


Eligibility Criteria:
Inclusion Criteria:

* endotracheal mechanical ventilation for 48 hours or more for acute respiratory failure in chronic respiratory failure patients (obstructive or restrictive disease),
* patient ready to be weaned (steady respiratory and hemodynamic conditions for 24 hours),
* spontaneous breathing trial failure occurring between 5 minutes and 2 hours, judged on clinical and/or arterial blood gas tolerance,
* written informed consent obtained (patient or family)

Exclusion Criteria:

* respiratory and hemodynamic instability
* initial intubation considered as difficult
* swallowing disorders suspected
* inefficient cough
* bronchial hypersecretion at the weaning time
* non cooperant patient
* contra-indications for nasal or facial mask (facial skin lesions,...)
* recent history of upper gastro-intestinal surgery
* recent history of myocardial infarction
Parenting and CAH - 21-hydroxylase Deficiency

Congenital adrenal hyperplasia (CAH) is a genetic disease with autosomal recessive transmission, which is defined by a deficiency of one of the steroidogenesis enzymes. 21-hydroxylase deficiency (21OHD), related to mutations of the CYP21A2 gene, is involved in 90 to 95% of CAH cases. Depending on the severity of the mutations of this gene, there are severe forms known as "classic" (FC), with neonatal onset, and moderate forms known as "non-classic" (FNC), with onset later in childhood or after puberty. The classic form includes the salt-wasting form and the pure virilizing form, depending on the degree of aldosterone deficiency. The sexuality and fertility of women with classic 21OHD deficiency are impaired by several factors such as disruption of the gonadotropic axis due to overproduction of androgens and progesterone by the adrenal glands, and mechanical and psychological factors related to genital surgery. The fertility of these women improves over time, largely due to earlier treatment of CAH, improved therapeutic compliance and surgical advances in genital reconstruction leading to an increase in the percentage of patients who are sexually active. However, there is little data available, and even less on the course of pregnancy, its complications and its outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or over
* Patients with HCS due to 21-hydroxylase deficiency, confirmed genetically
* Patients who have been informed and do not object to participating in the research

Exclusion Criteria:

* Patients who do not speak French
* Patients who are not affiliated to a social security scheme or who are not entitled to it
* Patients under legal protection, or under guardianship or trusteeship.
Effects of Alogliptin on Pancreatic Beta Cell Function

It is reported that pancreatic beta cell function is already declined at pre-diabetic stage, impaired glucose tolerance (IGT). It has not been clarified whether inhibitors of the dipeptidyl peptidase IV enzyme (DPP-IV inhibitors) improve beta cell function on human pancreas, however, if efficacy is ensured, they may become the first medicine to be chosen for treatments of type 2 diabetes and IGT.

In this trial, a DPP-IV inhibitor, Alogliptin, or Metformin are given to diabetic patients whose HbA1c level is below 7.9%. Oral glucose tolerance test (OGTT) will be conducted before, a year after, and two years after the beginning of the trial and beta cell function will be evaluated.

Patients will be randomly allocated to two groups. They will receive either Alogliptin or Metformin.

Alogliptin: The investigators will start with 25 mg QD and the dose will be maintained.

Metformin: The investigators will start with 250 mg QD and the dose will be slowly increased to 750 mg TID. The dose increase is possible up to its maximum, 2250 mg, so that HbA1c is maintained below 6.9%. However, increase in dose with elder patients requires careful consideration.

Participants taking part in this study will receive dietary and exercise coaching. Participation in this study is expected to last up to 2 years.

Patients will terminate from the trial when their HbA1c exceeds 8.4% for more than three months.

The investigators will evaluate beta cell function by conducting 75 g OGTT before, a year after, and two years after the beginning of the trial. Alogliptin or Metformin will be stopped three days before the OGTT. The investigators will make sure that urine ketone is negative before an oral glucose load.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed as type 2 diabetes with HbA1c level below 7.9% and haven't received oral hypoglycemic agents or insulin treatments for the past three months.

Exclusion Criteria:

* Patients whose 75 g OGTT 30-minutes insulin secretion exceeds 100 μU/ml
* Patients with renal failure with serum creatinine level ≧ 1.2
* Patients with hepatocirrhosis
* Patients with proliferative diabetic retinopathy or worse
* Patients with acute infectious disease
* Patients who are treated with steroids
* Patients with cancer
* Pregnant patients
* Patients with malfunction of the heart (NYHA classification III-IV)
* Patients who are decided to be inappropriate subjects by study physicians