cyrilzakka/clinical-trials huggingface dataset:
MEtoclopramide, DExamethasone or Axoli to Prevent or Delay Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy

In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed chemotherapy-induced nausea and vomiting (CINV) induced by non- anthracyclines plus cyclophosphamide (AC) based moderately emetogenic chemotherapy (MEC).


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with histologically or cytologically confirmed solid cancer
* Starting with first cycle of chemotherapy of moderate emetogenic risk, which does not include a combination of anthracycline plus cyclophosphamide
* Age ≥ 18
* WHO ≤ 1
* Patient is able to understand and speak Dutch

Exclusion Criteria:

* Patient with nausea and/or vomiting in 48 hours before start of chemotherapy treatment
* Patient submitted to concomitant radiotherapy or submitted to radiotherapy 15 days before start of chemotherapy or planned to receive radiotherapy during 8 days after administration of chemotherapy
* Patient with concomitant severe comorbidy, such as: o Intestinal obstruction o Active peptic ulcer o Hypercalcemia o Uncontrolled diabetes mellitus o Pheochromocytoma o Tardive dyskinesia o Epilepsia o Active infective diseases o Brain - or leptomeningeal metastases o Psychiatrical disorders o Parkinsonism
* Current use of corticosteroids (similar to prednisone ≥ 10 milligrams per day)
* Current alcohol abuse
* Pregnancy
Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports

Rivaroxaban has been developed in the various clinical settings.Although cancer-associated DVT or PE was included in previously programs, limited patients of the total populations were cancer patients with totally implantable access ports in these studies. In this sense, investigators feel that new oral anticoagulants should be re-investigated in this highly specific patients group.Therefore, investigators are planning to conduct a prospective study to estimate the efficacy and safety of rivaroxaban for thromboprophylaxis in high-risk cancer patients with totally implantable access ports.


Eligibility Criteria:
Eligibility Criteria:

1. Age 18-75 years;
2. Patients with malignant tumors who received implantable access ports for treatment;
3. Eastern Cooperative Oncology Group (ECOG) class 0-1;
4. will have a life expectancy \> 3 months;
5. Expected survival of more than 6 months;
6. Khorana score ≥2 point.

Exclusion Criteria:

1. Patients with a history of allergies to rivaroxaban;
2. History of recent major or clinically relevant bleeding within the previous 4 weeks.
3. Patients with bleeding risks: thrombocytopenia (platelet count \< 50\*109/L), clinically significant active bleeding, active gastric ulcer disease, severe arterial hypertension, history of previous stroke; Inadequate renal function; creatinine clearance \< 30 ml/min；
4. Inadequate hepatic function: aminotransferase \> 3 times the upper limit of normal (ULN) (if liver metastasis, alanine aminotransferase \> 5 times the ULN
5. Patients requiring strong cytochrome P450 3A4 (CYP3A4) inducers (rifampin, phenobarbital) or strong CYP3A4 inhibitors (HIV protease inhibitor, systemic ketoconazole) treatments.
6. Plan of treatment with bevacizumab or other anti-cancer drugs known to increase the bleeding risk.
7. Patients who have had anticoagulant drugs for any other reason.
8. Women who are pregnant or breastfeeding.
Special Drug Use Investigation for Botox® (Botulinum) Spasticity (BOTOX is a Registered Trademark of Allergan, Inc.)

The objective of this post-marketing surveillance study is to collect safety, efficacy and usage data on botulinum injection in subjects with upper or lower limb spasticity on the long-term use in clinical practice and to identify the factors affecting the safety or efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with upper or lower limb spasticity
* Subjects must use botulinum injection for the first time

Exclusion Criteria:

* Not applicable
Measuring the Impact of Care in the Cognitive Behavioural Unit

The purpose of this study is to compare the rate of re-hospitalizations in relation to a disruptive behaviour disorder (at 3 and 6 months) between patients who have received care in Cognitive Behavioural Unity (UCC ) and those who have received care in Geriatric Follow-up and Rehabilitation Care Unit (SSR).

The purpose of this muliticentric non-interventional study is to compare the rate of re-hospitalization in relation to a disruptive behaviour disorder between patients receiving care in Cognitive Behavioural Unity UCC (target arm) and those who have received care in Geriatric Care Unit and Rehabilitation SSR (Control arm ).

At Inclusion (Month 0) : Inclusion of patients admitted in UCC or in geriatric SSR units for less than 8 days after obtaining of their non opposition.

Following data: Socio-educational Level, somatic and psychiatric comorbidities, classification of the type of dementia, evolution of nutritional status, biology (hemoglobin, creatinine, albuminemia), cognitive evaluation, treatment, pain assessment, assessment of disruptive behaviour disorders, discharge modalities, assistance plan, legal protection (before and after hospitalization), types of restraints, measurement of fall rates and their consequences, pathology and/or symptoms observed ( incidents) during hospitalization and vital status will be collected at inclusion and follow-up (1, 3 and 6 months ).

At 1 month (M1), exit from hospitalization (M1): Data provided by Investigator .

At 3 months (M3) and 6 months (M6) after discharge from hospital in UCC or SSR: Sponsor's Clinical Research Associateall call patient (or his legal representative) or to the primary caregiver or attending physician or EHPAD coordinating physician for collection of questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* 70 ≥ years of age
* Patient with severe disruptive behaviour disorders with a score (Frequency X Severity) \>7 to at least one of the 7 items targeted on Clinician Neuropsychaitric Inventury (NPI-Es) scale
* Patient who was not cared for in Cognitive Behavioural Unit (UCC) within 6 months prior to admission
* Patient entered center less than 8 days
* Affiliation to a social security scheme
* Patient or legal representative has expressed his non-opposition

Exclusion Criteria:

* 70 \< years of age
* Patient with no score (FXG) \>7 to at least one of the 7 items targeted on Clinician Neuropsychaitric Inventury NPI-ES scale
* Patient who was cared for in UCC within 6 months of admission
* Entered Centre for 8 days or more
* Not affiliated or entitled to a social security scheme
* Patient or legal representative has expressed his opposition
Study to Describe Risk of Bleeding in Patients Depending on the Different Anticoagulant Therapy They Are on for Atrial Fibrillation (AF)

Study of patients with nonvalvular atrial fibrillation (NVAF) who are newly prescribed NOACs (Novel Oral Anticoagulants) in routine clinical practice in England


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of atrial fibrillation at or prior to index (the initiation of treatment)
* Incident prescription of an oral anticoagulant (index date)
* Patients with at least one year of computerized data prior to index date

Exclusion Criteria:

* Patients identified with a diagnosis of mechanical heart valve replacement or mitral stenosis identified at any point in the pre-index period in either CPRD by Read codes or in HES as ICD-10/OPCS codes
* Patients with indication of venous thromboembolism (pulmonary embolism or deep vein thrombosis) identified in in either CPRD by Read codes or HES by ICD-10/OPCS codes within 3 months prior to index

Other protocol defined inclusion/exclusion criteria could apply
Relationship Between Degree of Domestic Environmental Fungal Exposure and Clinical Symptoms of Patients With Chronic Obstructive Pulmonary Disease

Exposure to Aspergillus spores is associated with symptoms of asthma or airway inflammation (Chaudhary \& Marr, 2011; Smith \& Denning, 2011), leading to the possible onset of severe fungal complications with acute or chronic inflammation. In patients with chronic obstructive pulmonary disease (COPD), whose main etiological factor is cigarette smoke, A. fumigatus sensitization has been reported to be related to poor lung function (Bafadhel et al., 2014). Besides, COPD patients with fungal sensitization exhibit greater granulocyte count, implying more severe inflammation (Agarwal, Gaur, \& Chowdhary, 2015). Fungal cultures from sputum are frequently positive in patients with asthma or with COPD (Pashley, 2014). Fungal colonization and infection have also been suspected to be related to exacerbations of COPD, but their potential role in the pathogenesis of COPD is poorly understood (Bafadhel et al., 2014). The hypothesis is that patients with COPD have a worsening of their pulmonary symptoms after exposure to fungal spores. This study will ensure the feasibility of quantifying environmental fungal exposure in patients' dwellings. For this, an electrostatic wipe will be deposited in the living room and another one in the bedroom for 12 weeks. The wipes will be analyzed by the mycology laboratory of the Croix Rousse hospital.

If the results of this first study are conclusive, it is planned to continue this analysis with a regional multicentre study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged over 40
* Suffering from COPD (chronic obstructive pulmonary disease), diagnosed by a pulmonologist
* Presence of bronchial obstruction with FEV1 (Forced expiratory volume)/FVC (Forced vital capacity) \<70%
* FEV reversibility post β2-mimetic \< 12% and \< 200 ml (vs FEV prebronchodilator)
* Smoking ≥ 10 PA active or not
* Occupied the same residence for at least 12 months
* No changes to the home or recent work in the 6 months preceding inclusion
* Delivery of enlightened information and collection of non-opposition

Exclusion Criteria:

* Other chronic respiratory diseases: asthma, bronchiectasis,
* bronchial cancer, pulmonary fibrosis, diseases requiring the use of immunosuppressive treatment or biotherapy, or any long-term treatment with oral corticosteroids used for the treatment of a disease other than COPD
* COPD exacerbation of less than 4 weeks
* Treatment with inhaled corticosteroids alone,
* Long-term treatment with oral corticosteroids
* Persons deprived of liberty by a judicial or administrative decision,
* people undergoing psychiatric care, people admitted to a health or social establishment for purposes other than research
* Adults subject to a legal protection measure
* Patient enrolled in interventional research excluding routine care research (former regulations) and category 2 research that does not interfere with the analysis of the primary endpoint
S-1, Oxaliplatin, and Irinotecan for Advanced Gastrointestinal Cancer

This study will attempt to determine the feasibility of combination of Oxaliplatin, Irinotecan, and S-1, the maximum tolerated dose and the recommended doses of the agents used, and to preliminarily evaluate the antitumor activity in untreated patients with advanced gastrointestinal cancer.

Oxaliplatin or irinotecan has shown a considerable anti-tumor activity, when used in combination with 5-fluorouracil (5-FU) in patients with gastrointestinal (GI) cancer. Oxaliplatin, irinotecan, and 5-FU have different mechanisms of actions and do not share the toxicity profiles. Since they have a synergistic effect, many clinical trials have been conducted recently to evaluate the efficacy of triplet combination consisting of oxaliplatin, irinotecan, and 5-FU, and demonstrated that the triple combination regimen was effective and resulted in survival benefits with favorable toxicity profiles.

S-1 and capecitabine are novel oral fluoropyrimidines and different phase III trials have shown that these oral agents are at least as active and effective as 5-FU with a superior safety profile.

Biweekly triple combination of S-1 with oxaliplatin and irinotecan (OIS) is an interesting alternative to increase convenience and to simply the treatment delivery.

In the present study, we attempt to determine the feasibility of OIS combination, the maximum tolerated dose and the recommended doses of the agents used, and to preliminarily evaluate the antitumor activity in untreated patients with advanced gastrointestinal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven recurrent or metastatic adenocarcinoma of the gastrointestinal tract
* Minimum age of 18 years
* ECOG Performance status 0-2
* Life expectancy \>3 months
* Presence of measurable or evaluable disease by RECIST
* Prior adjuvant chemotherapy without S-1, oxaliplatin and irinotecan is allowed if more than 4 weeks elapsed since completion of chemotherapy.
* More than 4 weeks since completion of prior radiotherapy (measurable or evaluable lesions should be outside the radiation field)
* Adequate organ functions
* Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria:

* Patients treated previously with S-1, oxaliplatin, or irinotecan as adjuvant chemotherapy.
* Patients with CNS metastases or carcinomatous leptomeningitis or neurologic disease.
* Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding
* Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix
Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis

This is a multi-center, double-dummy, double-blind, randomized, active-controlled, parallel group phase 3 clinical trial to evaluate the efficacy and safety of KALOMIN™ Tab. in patients with acute bronchitis.

The aim of this clinical trial is to demonstrate that KALOMIN™ Tab. is clinically non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the treatment of acute bronchitis after 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 12-75 years old
* A total score of BSS ≥ 5
* The duration of symptoms had to be less than 14 days and no chronic pulmonary disease
* Patients who voluntarily sign a written informed consent to participate in the trial

Exclusion Criteria:

* Indication for antibiotic treatment(e.g. severe respiratory infection)
* Allergic bronchial asthma
* Tendency to bleed
* Severe heart, renal, or liver diseases or decline of immune function
* Chronic obstructive pulmonary disease
* Known or supposed hypersensitivity to investigational medication
* Treatment with antibiotics during the past 4 weeks prior to inclusion in the trial
* Women during pregnancy or lactation period
* Clinically significant abnormal values in the screening test(more than twice the upper limit of normal range for ALT, AST, BUN, and Serum Creatinine)
* Participation in any other trial within 30 days prior to inclusion in the trial
* Unsuitable patients for enrollment in the opinion of the investigator
Photobiomodulation for Dry Age Related Macula Degeneration

The study will investigate the effect of photobiomodulation treatment on the risk of developing late age related macula degeneration (AMD) in the study eye in patients with wet AMD in the fellow eye.


Eligibility Criteria:
Inclusion Criteria:

* patients with dry AMD in the study eye and wet AMD in the control eye

Exclusion Criteria:

* Geographic atrophy of the central macular region at enrolment
* Previous/ active wet AMD in the study eye
* A history of epilepsy
* Retinal diseases apart from AMD
* Significant media opacities
* Cataracts worse than grade 2 (LOCS III classification)
* Change in AREDS 2 supplements (vitamins) 1 month before the study and during the study trial was allowed.
* Ongoing systemic medications that are photosensitizing (e.g. tetracyclins)
* Systemic medications during the last 6 months that can cause deposits in the macular region (hydroxychloroquine, amiodarone)
* Unable to give informed consent
* Unable to cooperate with the treatment and follow-up
A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

This study evaluated the effect of inhaled aclidinium bromide on exercise endurance and in reducing resting and dynamic lung hyperinflation in patients with moderate to severe COPD. It was 9 weeks in duration, consisting of; a 2-week run-in period, 6 weeks of double-blind treatment, and a 1-week follow-up phone call. All patients meeting the eligibility criteria were randomized to one of two treatment groups: aclidinium bromide or placebo.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of stable moderate to severe COPD (GOLD 2006); post-levalbuterol FEV1 \>=30% and \< 80% predicted and FEV1/FVC\<70% predicted
* Current or former cigarette smoker
* Functional Residual Capacity (FRC) measured by body plethysmography \>= 120% of predicted value
* Baseline Dyspnea Index (BDI) focal score ≤ 7 at Visit 4

Exclusion Criteria:

* History of presence of asthma, allergic rhinitis, or atopy
* Hospitalization for acute COPD exacerbation in the 3 months prior to study entry
* Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
* Clinically significant respiratory conditions other than COPD
* Chronic use of oxygen therapy \>= 15 hours a day
Molecular Characterisation of Colorectal Cancer Peritoneal Metastases

This project aims to characterise the tumour cell and tumour microenvironment of colorectal cancer peritoneal metastases, understand molecular changes leading to colorectal peritoneal metastasis, identify potential biomarkers and novel treatment strategies.

The peritoneum is the second most common site for recurrence in colorectal cancer (CRC). Cancer spread to the peritoneum (colorectal cancer peritoneal metastases, CRPM) cause severe symptoms in patients and lead to shortened survival. The only definitive treatment available is a complex and aggressive surgical procedure involving radical removal of organs and the internal lining of the abdomen.

The biology of CRPM and correlations with clinical outcomes has been reported in small numbers of patients. There has been limited research on how extended cancer mutations lead to metastases and how this can affect treatment or survival. Understanding how genetic mutations evolve in CRPM and the role of the tumour microenvironment are important for optimising treatment and prevent the spread of cancer.

This study proposes completing cancer genetic profiling on archived tissue removed routinely from patients who previously have had surgery for CRPM. High through-put laboratory techniques for analysing the genetic profile of CRC and CRPM has the power to identify mutation patterns than might predict for treatments and survival outcomes. The results of genetic tests can then be compared to clinical characteristics, such as survival and treatments received. Genes in primary colorectal cancer can be compared to those in CRPM to describe what changes during the metastatic process.

This study will help make progress towards better and personalised treatment options, identifying predictors of treatment success and long-term survival. Improved treatments and better selection of patients may ultimately improve quality of life and help patients live longer.

Eligibility Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:

1. Patients ≥ 18 years old who have been diagnosed with colorectal cancer and have colorectal peritoneal metastases,
2. have had cytoreductive surgery at the Christie
3. have availability of archival tumour tissue (paired CRC and CRPM)

Exclusion Criteria:

* None
Outpatient Orthognathic Surgery: "AMBOST" a One Year Study

The aim of this prospective and observational study is to describe the conditions of orthognathic procedures performed in Toulouse Teaching Hospital over a one-year period, the outpatient-to-inpatient shifts rate and the whole outpatient rate among the whole orthognathic procedures done. The investigator also wants to identify factors associated with an outpatient-to-inpatient shift, and factors associated with the duration of hospitalization.

In Toulouse Teaching Hospital, the annual number of orthognathic surgery outpatient stays was multiplied by 6 since 2010, indicating a new trend of theses procedures. Outpatient stays presents several advantages for the patient and for the health system: decrease of the psychological stress, higher satisfaction, minimization of the personal and domestic activity interruption, less exposure to nosocomial infections, decrease of global costs, increase of the population rate which can be treated. However, very few data report the experience of outpatient orthognathic surgery in France and the factors associated with its success or failure.

The choice of ambulatory versus complete hospitalization is decided during preoperative consultation by the surgeon in agreement with the patient. The classic surgical and anesthetic protocol of orthognathic surgery is applied whatever the type of hospitalization. The data are collected from the patient medical record (electronic patient record, orthognathic follow-up form, anesthetic sheet) and from a patient quality of life questionnaire. There is no modification of the usual follow-up, patients are seen at D-8 which is the end-study visit.

Eligibility Criteria:
Inclusion Criteria:

* all patients treated by an orthognathic surgery in Toulouse Teaching Hospital, having given an oral agreement

Exclusion Criteria:

* patient refusal
* inability to understand the information relative to the procedure, the care and the surgical suites
* American Society of Anesthesiology (ASA) Score\>=3
* Severe eating disorders
* Pregnant woman