cyrilzakka/clinical-trials huggingface dataset:
A Retrospective Protocol Empowering Precision Research in Colorectal Cancer (ALFAOMEGA-RETRÒ)

ALFAOMEGA-RETRÒ will be exploited to retrospectively collect clinical and imaging data and archival samples to be used for validation and correlative studies on markers discovered by cutting-edge translational projects within the AIRC5x1000 program "Insights into the evolving heterogeneity of colorectal cancer (CRC): from mechanism to therapies" (an ongoing multi-institutional research program).

ALFAOMEGA-RETRÒ, the retrospective "mirror" protocol of ALFAOMEGA (protocol n. IFOM-CPO003/2018/PO002), has been designed to build a retrospective collection of clinically annotated data and biological samples retrieved from colorectal cancer patients (CRC).

The repository will feed experimental precision research aimed at i) defining a new taxonomy of CRC based on evolutionary patterns (retrospectively assessed on patient's samples), ii) developing and evaluating innovative biomarker-specific therapeutic strategies derived from or together with ALFAOMEGA.

The following data and biological samples will be collected:

* Clinical Data (Demographics, Medical History, Cancer Diagnosis \& History, Treatment Assessment,).
* Imaging Data (CT-Scans, MRI, PET...).
* Formalin-Fixed Paraffin-Embedded (FFPE) tissue (either from surgical resections or diagnostic biopsies).
* Frozen biological samples (blood, plasma, PBMC, stools, buccal swabs, urines, etc.).

Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed diagnosis of colorectal cancer (any stage).
* Age \>18 years at the time of diagnosis.
* Availability of clinically-annotated radio-imaging data and/or diagnostic Formalin-Fixed Paraffin Embedded (FFPE) blocks (surgical resections and/or tumor biopsies), or at least 10 slides (preferably 20). FFPE tissue blocks are always preferred to slides.
* Verification that the patient could not be reached for informed consent in accordance with applicable national regulations.

Exclusion Criteria:

* if inclusion criteria are not met
Evaluation of a Gel Sunscreen in Controlled Use Conditions (208/2016)

To explore and quantify potential issues with application of a gel sunscreen in Outdoor Use testing, in a controlled indoor environment


Eligibility Criteria:
Inclusion Criteria:

* Subjects may be male or female.
* Subjects must be adults between 18 and 45 years of age.
* Subjects must have and have had a consistently active lifestyle for at least the previous few years (exercise
* outdoors and in direct sun exposure at least 2 times per week for at least 30 minutes-acceptable activities include tennis, running, jogging, walking, golf, etc.), i.e., outdoor activity should not be a new behavior.
* Subjects must have used a sunscreen with SPF 50 or higher within the previous 9 months.

Exclusion Criteria:

* Subjects who have received or used an Investigational New Drug within the last 30 days.
* Subjects who have been active participants in another clinical or subjective product performance study within the last 30 days.
* Subjects who have a known allergy or sensitivity to sunscreen ingredients or test materials.
* Subjects with respiratory allergies or asthma.
Jaundice as Initial Presentation of Liver Hydatidosis (ICTEHIDA)

The aim of this study is to evaluate patients with hepatic hydatidosis whose symptom at diagnosis was obstructive jaundice. As well as analyzing, the rate of performing preoperative ERCP, the results after surgery and morbidity

Retrospective study of patients operated on for liver hydatidosis and whose initial symptom was obstructive jaundice Study period: January 2006 to September 2018

The preoperative diagnosis was based on abdominal ultrasound (US), CT scan or magnetic nuclear resonance

Surgical technique Precautions are taken to avoid the spillage of the parasite in the abdominal cavity. The peritoneal cavity is liberally protected with scolicidal agents. All patients have intraoperative ultrasound. Ultrasound is performed to locate the presence of any cysts which might not be seen by the preoperative imaging. Intraoperative ultrasound is also used to find out the relation of the cyst to the big vessels. Depending on the intraoperative findings, the location and size of the cyst will be considered the type of surgery to be performed. Radical surgery (closed and open total cystopericystectomy, or liver resection) or conservative surgery (partial cystopericystectomy, removal of the vesicles with external or internal drainage). When the cyst affects a total lobe and / or the main pedicles, a hepatectomy is performed.

The demographic data of the patients will be taken from their clinical histories. It included age, sex, medical history of hidatidosis, clinical findings, laboratory data, radiological findings, endoscopic treatment, surgical treatment.

The investigators will analyze postoperative mortality and morbidity. Complications' ranking according to the Clavien-Dindo score, 'severe complication' is defined as greater or equal to IIIa

Follow-up The follow-up of these patients will be performed with ultrasound or CT and hydatid serology. The minimum follow-up of the patients is six months. Relapse is defined as the appearance of new active liver cysts after the patient had undergone surgery.

Eligibility Criteria:
Inclusion Criteria:

* Hepatic Hydatidosis with obstructive jaundice surgically treated

Exclusion Criteria:

* Patients with conservative treatment
Study Assessing Long-teRm Outcomes of dupiluMAb (DUPIXENT®) Treatment in Adult Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)

The primary objectives of the study are:

* To longitudinally characterize the long-term effectiveness of DUPIXENT® through assessment of patient-reported symptoms, Health-Related Quality of Life (HRQoL) related to Chronic rhinosinusitis with nasal polyposis (CRSwNP) and other type 2 comorbidities, and their change over-time.
* To characterize patients who receive DUPIXENT® for CRSwNP in a real-world setting with respect to their medical history, demographic and disease characteristics, and type 2 comorbidities

The secondary objectives of the study are:

* To characterize real-world utilization of DUPIXENT® for patients with CRSwNP
* To collect patient and physician global assessment of disease severity and treatment satisfaction for patients receiving DUPIXENT® for CRSwNP
* To collect long-term safety data for patients receiving DUPIXENT® for CRSwNP


Eligibility Criteria:
Key Inclusion Criteria:

* All patients who are newly initiated on DUPIXENT® for the treatment of CRSwNP according to the respective prescribing information (Product Label or SmPC)
* Willing and able to comply with clinic visits and study-related procedures as per protocol
* Provide informed consent signed by study patient or legally acceptable representative
* Able to understand and complete study-related questionnaires as per protocol

Key Exclusion Criteria:

* Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information
* Any previous treatment with DUPIXENT® for any condition
* Any condition that, in the opinion of the investigator, may interfere with the patient's ability to participate in the study per protocol
* Participation in an ongoing interventional or observational study that might, in the treating physician's opinion, influence the assessments for the current study per protocol
Efficacy of 500µg Roflumilast Once Daily Versus Placebo Over 12 Weeks in Patients With Diabetes Mellitus Type 2. A Double Blind, Parallel Group, Proof of Concept Clinical Study

This study is a proof of concept study to confirm in a standardized manner the therapeutic efficacy of roflumilast in type 2 diabetes mellitus patients.


Eligibility Criteria:
Inclusion Criteria:

* given written informed consent
* patients with diagnosis of type 2 diabetes according to American Diabetes Association (ADA) criteria and inadequately controlled on diet and exercise alone
* HbA1c at baseline: ≥7.5 percent to 8.5 percent (up to 9 percent in Mexico, Ukraine and Romania)
* BMI between ≥26 and ≤35 kg/m2
* willingness of patient to check his/her blood glucose with equipment provided by the sponsor during the treatment phase in case of hypo-/hyperglycemia episodes
* willingness to adhere to the physician's advise to comply with diet and exercise

Main Exclusion Criteria:

* patients diagnosed with type 1 diabetes or diabetes secondary to pancreatitis or resection of pancreas
* patients diagnosed with hemoglobinopathies, hemolytic anemia or other diseases which interfere with HbA1c measurement
* non-euthyroid patients or patients with a non-controlled hypo- or hyperthyroidism
* reported gain or loss of more than 5 percent of body weight within the last 2 months prior to V0
* treatment with any diabetes medication prior to V0
* treatment with any weight-loss medication within 3 months prior to V0
* treatment with any not allowed medication or nutrition additives
* clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
* clinically significant cardiac abnormalities (diagnosed clinically, or by X-ray/ECG) that were not related to type 2 diabetes mellitus and that required further evaluation
* participation in a clinical study with study medication for weight loss or type 2 diabetes

Patients were randomized after 2 weeks of the baseline period, if the following criteria were fulfilled:

* judged to be clinically stable
* tablet compliance ≥80 percent and ≤125 percent
* HbA1c in the range of 7.5 percent to 8.5 percent (up to 9 percent in Mexico, Ukraine and Romania) tested at V0 by the central laboratory
Timing of VTE Prophylaxis in TBI

This study compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients in both treatment groups will be monitored for development of VTE as well as complications from bleeding after commencement of VTE prophylaxis.

This a randomized prospective study that compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients who are identified as having an intracranial injury will be randomized to early versus late VTE prophylaxis using a 1:1 random numbers allocation. Patients in both treatment groups will be monitored for development of VTE, primarily with scheduled duplex ultrasound studies of the lower extremities. Any clinical suspicion of VTE will also be investigated with duplex ultrasound and/or CT angiogram of the chest. Patients will be monitored for development of complications from bleeding post commencement of VTE prophylaxis. Intracranial bleeding complications will be monitored by physical examination and CT scanning of the head when indicated. Patients who undergo craniotomy or craniectomy will have VTE prophylaxis started 72 hours post-surgery and will undergo CT scan of the head (to assure bleeding stabilization) prior to administration of VTE prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic brain injury
* Intracranial hemorrhage on CT scan

Exclusion Criteria:

* Under the age of 18
* Pregnant
* Die within 24 hours of admission
* Hospital stay less than 5 days
* Contraindications to enoxaparin or heparin
* Coagulopathy at 24 hours post-injury defined as INR\>1.6 aPTT\>2x normal, or platelet counts\<50k
* Known history of VTE
An Open Trial to Assess the Tolerability of AVANZ® Cupressus Immunotherapy

This trial is an open, national, multi-centre trial. The main objective of this trial is to assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica by measurement of related Adverse Events.

The main objective of this trial is to assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica, the measurement rate is the frequency of patients with investigational medicinal product (IMP)-related adverse events (AEs) will be the primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

* A documented clinically relevant history of Cupressus arizonica pollen induced allergic rhinoconjunctivitis with or without asthma for at least one year prior to trial entry.
* Positive Skin Prick Test (SPT) response to Cupressus arizonica pollen (wheal diameter ≥ 3 mm)

Exclusion Criteria:

* History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
* Previous treatment with immunotherapy with Cupressus arizonica pollen extract within the last 5 years (initiation of subcutaneous immunotherapy is acceptable if treatment has been discontinued before reaching maintenance dose; for SLIT 3 months in the last 5 years is accepted).
* Ongoing treatment with any allergen-specific immunotherapy product.
* A history of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise-induced, food allergy, drugs or an idiopathic reaction).
* A systemic disease affecting the immune system (e.g. insulin-dependent diabetes, autoimmune disease, immune complex disease, or immune deficiency disease whether acquired or not).
Angiotensin II for Septic Shock Treatment

This study aims to investigate the effect of angiotensin II on microcirculation and peripheral perfusion in patients with septic shock.

Shock is a syndrome characterized by acute circulatory failure resulting in impaired peripheral tissue perfusion. Distributive shock is the most common type of shock and is usually caused by severe sepsis. Distributive shock is characterized by profound vasodilatation leading to decreased arterial blood pressure and impaired organ perfusion despite high cardiac output.

The use of vasopressors is an essential management line for distributive sock. Two groups of vasopressors are usually used for management of shock: catecholamines and vasopressin-like peptides. There is a continuous need for other vasopressors because:

1- Available vasopressors have narrow therapeutic window. 2- Patients with severe hypotension refractory to the currently available classes usually die.

A third system is usually engaged in the physiology of shock which is Renin-Angiotensin-aldosterone system. Angiotensin II is a natural hormone which is a potent vasopressor; moreover, angiotensin II stimulates the production of both antidiuretic hormone and adrenocorticotropin hormone.

In a pilot study, angiotensin II was reported as an effective rescue vasopressor in septic shock patients on multiple vasopressors. Angiotensin II improved mean arterial pressure and helped in reduction of the doses of catecholamines. In a recent large randomized controlled trial, angiotensin II improved blood pressure in catecholamine-resistant distributive shock patients.

Microcirculation is the primary site of oxygen and nutrient exchange. Maintenance of microcirculatory perfusion is a prerequisite for preservation of organ function. Multiple organ failure is common in patients with distributive shock despite maintenance of parameters of global perfusion due to disrupted microcirculatory perfusion. Furthermore, restoration of microcirculatory perfusion was correlated with improvement in survival. This study aims to investigate the effect of angiotensin II on peripheral microcirculation in patients with septic shock.

Eligibility Criteria:
Inclusion Criteria:

* Septic shock patients.
* Aged above 18 years.
* With cardiac index \> 2.4 L/min/BSA 1.73 m2.
* On high dose vasopressors (defined as norepinephrine infusion above 0.1 mcg/Kg/min)

Exclusion Criteria:

* Acute coronary syndrome.
* Impaired cardiac contractility
* Bronchospasm.
* Major burns
* Liver failure.
* Active bleeding.
A Randomized Double-blind Trial With 6 Antipsychotic Drugs for Schizophrenia

The purpose of this study is to compare the efficacy and side effects of 6 commonly used antipsychotic drugs in the treatment of schizophrenia in a Chinese population.

The relative effectiveness of second-generation (atypical) antipsychotic drugs as compared with that of older agents has been incompletely addressed, though newer agents are currently used far more commonly. The investigators compared a first-generation antipsychotic, perphenazine or haloperidol, with several newer drugs in a double-blind study.

METHODS: A total of 550 patients with schizophrenia were recruited at 4 Chinese sites and randomly assigned to receive perphenazine (16 to 64 mg per day) or haloperidol(6 t0 20mg per day), olanzapine (5 to 20 mg per day), quetiapine (400 to 750 mg per day), aripiprazole (10 to 30 mg per day) or risperidone (2 to 6.0 mg per day) for up to 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients' diagnoses is based on the results of the Structured Clinical Interview for DSM (SCID) using the criteria of the fourth edition of the Diagnostic and Statistical Manual (DSM-IV), physical exams and routine chemistry, and hematology laboratory tests. Attending-level psychiatrists will use a Chinese translation of the SCID to interview patients and their family members, who are given freedom to ask additional questions if respondents do not understand the standard probes.
* Patients must meet the following criteria: (1) diagnosis of schizophrenia; (2) duration of illness more than 2 years; (3) between 25 and 60 years of age; and (5) have NOT received antipsychotic medication for at least 1 month;(6) acute exacerbations of chronic inpatients.
* A complete medical history, electroencephalograms and electrocardiogram are obtained, and a physical examination and laboratory tests are performed at study entrance. None of the study participants have abnormal findings on these tests.

Exclusion Criteria:

-
Evaluation of a Regional Healthy Skin Program in Remote Aboriginal Communities of Australia's Northern Territory

The purpose of this study is to determine whether a coordinated regional approach to healthy skin programs in six remote Aboriginal communities can demonstrate, not only a reduction in the burden of scabies and streptococcal skin sores, but also broad health benefits, including primary prevention of some chronic diseases that occur at particularly high rates in Australian Aboriginal communities.

The primary objectives of the Program are:

* Demonstrate a reduction in scabies and skin sores on a regional basis
* Demonstrate the broader public health effects of Healthy Skin Programs, particularly those relating to chronic diseases such as rheumatic fever and renal diseases
* Build on the existing Indigenous capacity by assisting in the development of new knowledge and skills to improve the health and well being of Indigenous communities
* Establish the feasibility of incorporating Healthy Skin Programs into existing health service delivery

There are standard government recommendations for the conduct of healthy skin programs within the Northern Territory (NT), where the key component involves a single mass treatment for scabies of all residents in the region followed by regular monitoring of skin infections with treatment of individuals as new cases arise. The key features of the guidelines include:

* Community planning and collaborative effort;
* Development of local educational resources;
* Single whole community treatment day for scabies with permethrin (5%);
* Community "clean up" involving house cleaning, linen and rubbish collection;
* Emphasis on housing functionality and "washing kids" to maintain low rates of skin sores; and
* Regular monitoring of scabies and skin sores, usually in a target group such as children

Previous programs have been successful in controlling scabies and related skin infections in the NT but have been limited to single communities with varying levels of success. In collaboration with communities in the East Arnhem Region, we propose to conduct a coordinated Healthy Skin Program. By concentrating on one region, the project has an increased likelihood of success because reinfection due to mobility between communities will be minimised, and because the project will be recognised as a collaboration between multiple communities.

The program is structured into three distinct components:

* Implementation of the program within the participating communities;
* Evaluation of the program against specific outcomes; and
* Integration of the program into routine service delivery.

Eligibility Criteria:
Inclusion Criteria:

* All children aged \<15 years in the participating communities

Exclusion Criteria:

* None
Retrospective Survey of Hyperkalemia in Hemodialysis

This study aim to describe hyperkalemia clinical burden and investigate the risk factors associated with the burden on HD facility level.

This study is an observational survey study. We estimate 300 hemodialysis (HD) centres will be enrolled in the study. Summarized data on serum potassium (sK) after long interdialytic interval (LIDI), facility practice pattern and patient characteristics which may be related with sK management, and death records information including number of deaths for each centre will be collected. All the data collected and analysed are on HD facility level, not on patient-level. We are aiming to describe hyperkalemia clinical burden and investigate the risk factors associated with the burden on HD facility level. Association between sK management and long-term outcome will also be explored.

Eligibility Criteria:
Inclusion Criteria:

-

For HD centers:

* ≥ 100 patients under MHD within 3 years prior the study initiation
* Willing to participate in the study
* Have routine blood collection after LIDI
* Have death records

For HD patients:

• On chronic HD for ≥ 3 months

Exclusion Criteria:

* Blood test on other days than those after LIDI
* Unable to provide detailed data required by study protocol
* Being unable to comply with study-specified procedure
Comparison of in Vitro Fertilization Rates of Oocytes and Embryo Development Using Two Techniques of Semen Processing

The investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development.

The project is a RCT follow the orientation of CONSORT. The investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development.

Eligibility Criteria:
Inclusion Criteria:

* infertile women who will partcipate in an IVF programme

Exclusion Criteria:

* male factor of infertility