cyrilzakka/clinical-trials huggingface dataset:
Appropriate Compatibility of Propofol and Sevoflurane for Orthopaedic Surgery of Patients With MCI

According to the inclusion and exclusion criteria, elderly patients undergoing elective orthopedic surgery were randomly divided into four groups. The different combinations of propofol and sevoflurane were used in the four groups: 1 day before surgery, after patients become wide-awake, and 3 days, 7 days, and 3 months after surgery, the patient's cognitive function was evaluated using a professional cognitive scale and other indicators. Finally, statistical analysis.


Eligibility Criteria:
Inclusion Criteria:

* Elective orthopaedic surgery
* American Society of Anesthesiologists physical status: II

Exclusion Criteria:

* Neurological diseases that may affect cognitive function (e.g., subdural hematoma)
* Hypothyroidism
* Alcoholic dementia
Effect of Heliox on RSV Bronchiolitis

Helium is an inert gas with a density almost one-seventh of that of air. Based on its properties breathing a mixture of helium and oxygen (heliox) will lead to a reduction in resistance through narrowed airways and consequently decreases the work of breathing. Participating infants with RSV acute bronchiolitis will be supplied with heliox (ration of 21 oxygen and 79 helium) delivered through a flow nasal cannula to evaluate heliox effect in improving their oxygenation. Heliox will act as an additive therapy to improve oxygenation in patients with lower respiratory tract infection caused by respiratory Syncytial Virus (RSV) and will decrease the need for more complicated therapies.


Eligibility Criteria:
Inclusion Criteria:

* Age fro 1 month till 2 years
* RSV acute bronchiolitis without any supplemental oxygen.

Exclusion Criteria:

* oxygen supplement or mechanical ventilation requirement
* congenital anomalies of the heart
* chronic lung disease including bronchopulmonary dysplasia
* Failure to obtain an informed consent.
Patient-derived Xenograft (PDX) Modeling to Test Drug Response for High-grade Osteosarcoma

By obtaining clinical specimens from participants with high-grade bone and soft tissue sarcomas to establish and profile as freshly implanted tumors in mice, the aim of this study is to identify agents with predicted activity in the host patient while also potentially providing them with individualized cancer treatment options

Patient-derived xenografts (PDX) are increasingly used as tools for drug development in pre-clinical settings, and have been shown to recapitulate the histology and behavior of the cancers from which they are derived. Although, they have been commonly used productively as pre-clinical disease models to study disease biology and drug response, they have not been used prospectively to inform clinical management. PDX have been employed to inform clinical decision-making in small studies, which have shown high concordance between individual PDX and patient responses to therapy. While encouraging, the role of this approach in bone and soft tissue sarcomas and in the context of genomic drug matching strategies remains undefined. This has created an opportunity to evaluate the utility of PDX as clinical predictors to direct the use of chemo- and targeted therapies in combination with comprehensive genomic and epigenetic analysis for patients with bone and soft tissue sarcomas.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years;
2. Diagnosis confirmed histologically and reviewed centrally;
3. Prior treatment (completed \>4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high-dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD);
4. Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy \>3 months;
5. Adequate renal, hepatic, and hemopoietic function;
6. Normal or controlled blood pressure;
7. Surgery and/or radiotherapy completion at least 1 month before enrollment.

Exclusion Criteria:

1. Central nervous system metastasis;
2. Have had other kinds of malignant tumors at the same time;
3. Cardiac insufficiency or arrhythmia;
4. Uncontrolled complications, such as diabetes mellitus and so on;
5. Coagulation disorders;
6. Urine protein≥ ++;
7. Pleural or peritoneal effusion that needs to be handled by surgical treatment;
8. Combined with other infections or wounds.
NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers

The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2.

Evaluate pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult subjects who signed informed consent
* BMI of \>18.0 kg/㎡ and \<30.0 kg/㎡ subject, weight more than 50kg(45 kg or more for woman)

Exclusion Criteria:

* Subjects participated in another clinical trial within 6 months prior to administration of the study drug
* Inadequate subject for the clinical trial by the investigator's decision
* Subjects participated in another clinical trial within 6 months prior to administration of the study drug
14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin - Chameleon

to determine the ability of the test article to cause irritation to the skin of humans under controlled patch test conditions


Eligibility Criteria:
Inclusion Criteria:

* male or female, 18-70 years of age, in general good health
* normal skin
* free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, will interfere with the study results or increase the risk of adverse events
* of any skin type or race providing the skin pigmentation will allow discernment of erythema
* agree to complete a medical history and concomitant medication form
* read, understand and sign informed consent

Exclusion Criteria:

* have any visible skin disease at the study site which, in the opinion of the investigative personnel, will interfere with the evaluation
* are receiving systemic or topical drugs or medication which, in the opinion of the investigative personnel, will interfere with the study results
* have psoriasis and/or active atopic dermatitis/eczema
* have a known sensitivity to cosmetics, skin care test articles, or topical drugs as related to the test article being evaluated
* are females who are pregnant or breastfeeding or become pregnant
Genomic Testing and Resulting Medical Decisions

There is no evidence available about which molecular profiling methods are currently used for cancer patients in Austrian clinical practice. The construction of the registry proposed as a completely independent research endeavor, will be helpful for scientific evaluation and the establishment of highly credible data.

In the situation of enormous possible beneficial options for patients, health care systems, researchers and companies and the simultaneously present high number of uncertainties, the establishment of an independent registry for patients undergoing any type of comprehensive genomic profiling offers many advantages.

In particular, an overview of the speed of development, the "market penetration", the use of the technology in specific indications (tumor types, stages and in specific situations of unresponsiveness to certain drugs), the frequency by which treatment decisions will definitely follow the result of comprehensive genomic profiling and the reasons for this, the treatment outcome of such patients, the platform technologies applied (in-house (which types), vs. commercial) and the development of these parameters over time and in relation to the development of novel drugs will be analyzed.

The registry proposes to cover the time period from the years 2016 to 2019, which will allow for assessment of both the current and emerging landscape of genomic/molecular testing practice in Austria and effect of molecular profiling on patient care and outcome.

Eligibility Criteria:
Inclusion Criteria:

This registry will include cancer patients for which broad genomic profiling is indicated as assessed by the medical need and as deemed appropriate by the physician, for example

* cancer with high mutational load and suspicion of regular or frequent formation of neoantigens

  * skin, lung, stomach, esophagus, colorectum, bladder, uterus, cervix, liver, head and neck, kidney, breast
  * lymphoma B-cell
* any other neoplastic disease where molecular targeting is performed but treatment fails
* cancer of unknown primary origin (CUP)
* planned or already carried out comprehensive genomic testing as of Jan 1, 2016 note: this registry will not initially register patients who are tested for only 1-5 mutations by conventional means, but patients undergoing genomic profiling based on NGS)
* a patient´s signed informed consent
* Patients ≥ 18 years of age

Exclusion Criteria:

* Due to the non-interventional design of the registry there are no specific exclusion criteria.
Identification of Biomarkers Associated With the Presence of Malignant Pancreatic Lesions Compared to Benign Lesions.

The challenge for medical oncology is to develop plasma biomarkers that can detect the influence of the stroma on diagnosis, prognosis and response to chemotherapy.

Today, there is no validated blood test to help diagnose pancreatic cancer (PDAC). The search for blood biomarkers of the tumor stroma and immunological markers is therefore a major challenge in orienting the diagnosis towards PDAC and optimizing the therapeutic management of pancreatic cancers.

The aim of the study is to identify biomarkers associated with the presence of malignant pancreatic lesions (patients from the Pancreas-CGE cohort, a cohort already set up by our team) compared with benign lesions (patients followed up for benign pancreatic lesions). Candidate biomarkers from our preliminary work will be considered initially. Other biomarkers may be explored secondarily.

The ultimate goal is to develop a clinico-biological signature that is as efficient as possible in predicting the presence of malignant pancreatic lesions compared with benign ones.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥18 years
* Patient followed for benign pancreatic lesions:

chronic pancreatitis acute pancreatitis at a distance from the acute episode (\> 4 weeks) with indication for echo-endoscopy for suspected precancerous pancreatic lesions (PanIN, TIPMP, mucinous cystadenomas) or other cystic lesions (serous cystadenomas)

Exclusion Criteria:

* Malignant pancreatic tumor
* Legal incapacity or limited legal capacity
131I-rituximab for Relapsed or Refractory Follicular or Mantle Cell Lymphoma

Follicular lymphoma (FL) and mantle cell lymphoma (MCL) are rare lymphomas which consist of less than 5% of non-Hodgkin lymphoma in Korea. Although FL with histologic grade 1 or 2 has relatively good prognosis, continual treatment is needed due to frequent relapse. FL with histologic grade 3 has poor prognosis similar to that of diffuse large B cell lymphoma. Meanwhile, the response rate to systemic chemotherapy in MCL is low, so the treatment of relapsed MCL is challenging. So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with FL or MCL


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed follicular lymphoma or mantle cell lymphoma
* relapsed or refractory patients
* Eastern Cooperative Oncology Group performance status ≤ 2
* age≥ 20 years
* More than one measurable lesion (More than 2cm sized lesion in conventional CT scan,More than 1cm sized lesion in spiral CT or contrast-enhanced PET/CT)
* Adequate renal function (serum creatinine ≤ 2.0 mg/dl or Ccr ≥ 60 ml/min)
* Adequate hepatic function (serum bilirubin ≤ 2.0 mg/dl , AST/ALT ≤ 3 upper normal limit)
* Adequate bone marrow reservoir (ANC ≥1,500/㎕, platelet count≥ 75,000/㎕)
* patient who agree the purpose and intention of this clinical trial

Exclusion Criteria:

* recent (\<5 years) history of other malignancy or unrecovered from the disease (appropriately treated skin cancer and uterine cervix carcinoma in situ are excluded)
* hemodynamically unstable due to the recent (\<12 months) history of severe
* heart disease such as myocardial infarction
* acute complications of severe lung or metabolic disease
* Combined severe neurological or psychiatric disease
* Unrecovered from infection or other medical disease
* Recent (\<30 days) history of enrollment of other clinical trial
* Pregnant or breast-feeding woman
* women of childbearing potential and men not employing adequate contraception at least for 1 year
* previous history drug allergy to the content of 131I-rituximab
* Infection(sepsis, pneumonia, viral infection, etc) (inactivated hepatitis B carrier can be enrolled)
Evaluation Study of a Management Strategy for Gastroesophageal Reflux Disease (GERD)

The aim of this project is to compare the GERD clinical outcomes in patients where a structured pathway using the GerdQ questionnaire is implemented compared with the clinical outcomes of those treated without this implementation.

This is a European project with 5 participating countries (Austria, Italy, Norway, Spain and Sweden). Due to different characteristics regarding the actual management of this disease in the 5 countries, each country had the flexibility to introduce design differences and changes in the study protocol.

In Norway, it is developed as a clinical trial where a new structured pathway in the diagnosis and treatment of GERD is compared to the ordinary clinical pathway consisting of the endoscopic/pH-metry approach in patients referred from primary care to GI specialists.

In Italy, it is a PCP-level, cluster randomized, controlled trial comparing a structured clinical pathway versus usual care in patients with GERD. The implementation consists of training sessions on the clinical pathway with the selected PCPs (Implementation Group).

In Sweden, it is a cluster-randomised interventional study performed within daily clinical practice for the purpose of assessing the effect of the implementation of the structured clinical pathway in patients identified as having GERD. The participating PCCs will be randomised (1:1) to implement the structured clinical pathway or handling the patients according to local clinical routines.

In Austria and Spain, it is a cluster-randomized study to be developed within daily clinical practice for the purpose of assessing the effect of the implementation of the structured clinical pathway on GERD patients . The evaluation study will take place subsequent to a prior implementation of a clinical pathway. The implementation consists of a detailed explanation by training-materials about the clinical pathway in a selected randomized pool of PCCs. The implementation that will be evaluated is outside of the study procedures; it is the physician's decision whether to apply it or not.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with symptoms suggestive of GERD (heartburn or regurgitation as prevailing symptoms) of any severity
* Patient able to understand and complete the questionnaires

Exclusion Criteria:

* Alarm symptoms (Dysphagia/odynophagia, anorexia, anaemia, unintentional weight loss, abdominal mass, upper GI bleeding)
* If the patient is participating in any clinical trial, he/she cannot take part on this study
* Any condition that, in the investigator's opinion, makes the patient's participation in the study difficult
Comparison of an Acceleromyography- and Electromyography-based Neuromuscular Monitor With TOF-Watch ® Monitor

A quantitative neuromuscular monitoring device is desirable to titrate the depth of neuromuscular block (NMB) during a procedure, and to prevent residual effects after removal of the endotracheal tube. Unfortunately, the most widely used monitoring technique acceleromyography (AMG) typically implies a series of cumbersome installation and calibration procedures that frequently precludes correct use of these devices in clinical practice. Electromyography (EMG) has recently attracted a lot of attention as an alternative strategy to compensate for the deficiency of AMG-based neuromuscular monitors. Nowadays, a new technology that allows for the simultaneous acquisition of EMG and AMG signals is commercially available. Although its reliability has been rapidly accepted in Physical Medicine and Rehabilitation, the use of the technique in neuromuscular monitoring has never been reported. The aim of the present study is to assess the validity of the new device for estimating the neuromuscular block by comparing with TOF Watch®-SX, which is the most widely accepted AMG-based neuromuscular monitor that has been practiced in the clinical arena for decades.


Eligibility Criteria:
Inclusion Criteria:

* Age less than 18 yr
* American Society of Anesthesiologists Physical Status I to III
* Elective surgery requiring muscle relaxation
* Patients participated voluntarily and signed informed consent

Exclusion Criteria:

* Patients with known neuromuscular disorder
* Stroke
* Patients with a history of allergic reaction toneuromuscular blocking agents
* Use of medications that might interfere with neuromuscular transmission
* Any previous injury to the examined arm that might influence nerve conduction parameters
* Pacemaker
Molecular Signatures of HPV+ ORL Cancers (OROPAP)

The aim of this study is to identify HPV molecular signature in head and neck cancer to establish a new classification for positive human papillomavirus oropharyngeal tumor

OROPAP is a monocentric exploratory study with retrospective inclusion of patients.

The retrospective study focus on patients who have had surgery for HPV-positive oropharyngeal tumors whose survival is at least 2 year.

Frozen and or FFPE biopsies of these tumors and frozen blood samples are available via the HEGP biological resources platform.

The HPV molecular signatures will be identified by the capture-HPV technique.

For each patient, clinical-anatomo-pathological data such as tumor size, tumor stage, presence or absence of metastasis, histological stage, different treatment lines and 2-years survival data will be collected through the use of data warehouse available on the HEGP.

Eligibility Criteria:
Inclusion Criteria:

* Patients with HPV + oropharyngeal cancer

Exclusion Criteria:

* NA
A Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941

The purpose of this study is to evaluate the pharmacokinetics (PK) and safety following oral administration of ASP1941 in subjects with moderate hepatic impairment and in subjects with normal hepatic function based on the Child-Pugh Classification (CPC).

Study drug will be orally administered on Day 1. Subjects will be admitted to the clinic until completion of clinic discharge procedures on Day 7 with an outpatient follow-up visit 6-9 days after clinic discharge.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with Moderate Hepatic Impairment

  * Agrees to practice highly effective birth control until 7 days post dose. If female, two years post-menopausal, surgically sterile, and not pregnant or lactating
  * Weights at least 45 kg
  * Body mass index between 18 and 34 kg/m2
  * Meets criteria for moderate hepatic impairment defined by Child-Pugh method
* Subjects with Normal Hepatic Function

  * Agrees to practice highly effective birth control until 7 days post dose. If female, two years post-menopausal, surgically sterile, and not pregnant or lactating
  * Weights at least 45 kg
  * Body mass index between 18 and 34 kg/m2
  * Must have normal hepatic function defined by Child-Pugh method

Exclusion Criteria:

* Subjects with Moderate Hepatic Impairment

  * Has history or presence of biliary obstruction or biliary disease, hepatic encephalopathy, advanced ascites, portal hypertension, esophageal /gastric variceal bleeding, hepatocellular carcinoma, previous liver transplantation.
  * Has severe or moderate renal dysfunction
  * Known to be human immunodeficiency virus (HIV) positive
  * Has clinically significant history or presence of illness, malignancy or immunodeficiency
  * Has had a blood transfusion or donated / lost 450 mL of blood or more within 60 days of study drug administrations or donated plasma within 7 days prior to clinical check-in
  * Has history of alcoholism or drug/chemical/substance abuse within past 2 years
* Subjects with Normal Hepatic Function

  * Has severe or moderate renal dysfunction
  * Known to be human immunodeficiency virus (HIV) positive
  * Has clinically significant history or presence of illness, malignancy or immunodeficiency
  * Has had a blood transfusion or donated / lost 450 mL of blood or more within 60 days of study drug administrations or donated plasma within 7 days prior to clinical check-in
  * Has history of alcoholism or drug/chemical/substance abuse within past 2 years
Stimulatory Autoantibodies to the Platelet-Derived Growth Factor Receptor (PDGFR) in Patients With Systemic Sclerosis

This study is to determine if subjects with .systemic sclerosis have stimulatory autoantibodies to the PDGF receptor and to confirm activation (phosphorylation) of the PDGF receptor in skin sites with varying degrees of skin thickening

Pilot study to assess whether patients with systemic sclerosis have stimulatory autoantibodies to the PDGF receptor and to confirm activation (phosphorylation) of the PDGF receptor in skin sites with varying degrees of skin thickening

Eligibility Criteria:
Inclusion Criteria:

1. Fulfill the American College of Rheumatology criteria for systemic sclerosis or:
2. Have no diseases that result in primary fibrosis of an organ system, including the skin and do not have an autoimmune disease

Exclusion Criteria:

1. If the subject has systemic sclerosis resulting from an environmental exposure
2. If the subject has an autoimmune disease excluding scleroderma
3. If the subject has an active infection (including, but not limited to hepatitis B, hepatitis C and HIV)
4. If the subject has been treated with cyclophosphamide in the past 8 weeks.
5. If the subject is prone to bleeding because they are on medications that thin the blood or have a low platelet count.