cyrilzakka/clinical-trials huggingface dataset:
A Randomized Trial Of Endovascular Treatment For Acute Posterior Large Vessel Occlusion

The aim of this trial is to investigate whether endovascular treatment can improve the 90-day functional outcome of acute large vessel occlusion in the posterior circulation.

At least seven randomized controlled trials have consistently shown that endovascular treatment can improve the functional outcome of stroke patients with acute anterior large vessel occlusion. However, these trials did not include patients with large vessel occlusion in the posterior circulation.

The hypothesis of this trial: Compared with standard medical treatment alone, standard medical treatment combined with endovascular treatment can significantly improve the 90-day functional outcome of acute large vessel occlusion in the posterior circulation.

Eligibility Criteria:
Inclusion Criteria:

1. Age: i. 18 \~ 80 years old, pc-ASPECTS score ≥ 6; ii. \> 80 years old, pc-ASPECTS score ≥ 8 and mRS = 0 before the onset
2. NIHSS score ≥ 10 before randomization;
3. VA-V4 or basilar artery occlusion proved by CTA/MRA/DSA;
4. Time from stroke onset to randomization within 23.5 hours;
5. Written informed consent is obtained from patients and/or their legal representatives.

Exclusion Criteria:

1. CT or MR evidence of intracranial hemorrhage;
2. Pre-morbidity with a modified Rankin scale score ≥ 3;
3. The patient is in deep coma;
4. Currently in pregnant or lactating or serum beta HCG test is positive on admission;
5. Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
6. Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys;
7. Significant mass effect in the cerebellar hemisphere or hydrocephalus on imaging;
8. Imaging manifestations of diffuse bilateral brainstem ischemia;
9. Multivessel occlusive disease (combined with anterior and posterior circulation occlusion or subtotal occlusion);
10. Cerebral vasculitis, intracranial arteriovenous malformation, aneurysm, or brain tumor with mass effect;
11. Participating in other clinical trials;
12. Any terminal illness with life expectancy less than 6 months;
13. Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
14. Past neurological or psychiatric diseases that hinder the assessment of neurological function;
15. Unlikely to be available for 90-day follow-up.
Effects of Fresh Mango Pulp Consumption on Satiety and Cardiometabolic Health

The objective of the study is to determine the effects of fresh mango pulp consumption on satiety and metabolic parameters in overweight/obese adults.


Eligibility Criteria:
Inclusion Criteria:

* 18-55 years old
* BMI 27-40

Exclusion Criteria:

* Smoker
* Pregnant woman
* Required dietary supplement use
* Required medication of metabolic disorders
* Allergy to mango or gluten
Value of CT-based Autopsy Compared With Conventional Autopsy in ICU Patients

The aim of the study is to compare findings generated by CT-based autopsy (Virtopsy) with conventional autopsy and clinical diagnoses. Therefore all patients dying while receiving treatment in the Department of Intensive Care Medicine will be undergo virtopsy and, if relatives give informed consent conventional autopsy.

The aim of the study is to compare findings generated by computertomography-based autopsy (Virtopsy) with conventional autopsy and clinical diagnoses. Therefore all patients dying while receiving treatment in the Department of Intensive Care Medicine will be undergo virtopsy and, if relatives give informed consent conventional autopsy.

Eligibility Criteria:
Inclusion Criteria:

* Patients dying in the Department of Intensive Care Medicine while receiving treatment during the study period

Exclusion Criteria:

* None
The Efficacy of Serratus Anterior Plane Block (ESAPB) for Thoracotomy: a Prospective Study

Thoracotomy is considered the most painful surgical procedure. Ultrasound-guided serratus anterior plane block (SAPB) is a relatively new truncal block method treating thoracotomy pain. In this study, investigators aim to ascertain the efficacy of SAPB in thoracotomy.

Thoracotomy is considered the most painful surgical procedure, even with thoracic epidural analgesia (TEA) as a golden standard for acute post-thoracotomy pain. Ultrasound-guided serratus anterior plane block (SAPB) is a relatively new truncal block method treating thoracotomy pain, yet more evidence is needed to ascertain its efficacy.

This is a prospective study carried out in a tertiary hospital. Patients scheduled for thoracotomy are randomized into two groups: Group M (intravenous patient-controlled-analgesia morphine) and Group S (intravenous patient-controlled analgesia morphine and SAPB). Morphine consumption, VAS pain score and Prince-Henry pain score are recorded for 72 hours respectively at PACU, 2hr, 6hr, 12hr, 24hr, 48hr and 72hr, with heart rate, systolic pressure, diastolic pressure, mean arterial pressure and SpO2. Moreover, the profile of opioids-related side effects and length of hospital stay are documented. The primary objective of the study is to evaluate the efficacy of SAPB. The secondary objective is to compare the opioids-related side effects (including nausea, vomiting and pruritus), hemodynamic parameters and the length of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* BMI 18-28kg/m2
* Wedge incision and lobectomy

Exclusion Criteria:

* Uncontrolled hypertension or chronic conditions
* History of opioid dependence
* Allergy to bupivacaine hydrochloride
* Severe bleeding during operation or post operation
* Inability to communicate with investigators.
Attention Bias Modification Treatment for Major Depressive Disorder in Adolescents

In this study, we test whether a two-week 8-session neutral attention bias modification (ABM) training and a two-week 4-session positive ABM could reduce depressive symptoms relative to placebo controls in adolescents with major depressive disorder at posttraining and follow-ups during one year.

Depression is a common health problem in adolescents. Negative attentional bias has been theorized to play a critical role in the onset and maintenance of depression, suggesting that reduction of such biases may treat symptoms of depression. Recent studies have shown that attention bias modification(ABM) training could reduce depressive symptoms in both dysphoria and previously depressed adult patients.To test the effectiveness of ABM training on the treatment of depressive symptoms in depressed adolescents, we designed a randomized, double-blind, placebo controlled trial in adolescents with major depressive disorder(MDD).

Eligibility Criteria:
Inclusion Criteria:

* Meet the major depression disorder's criteria

Exclusion Criteria:

* bipolar disorder, schizophrenia or organic mental disorder;
* any concurrent psychotherapy;
* any concurrent psychotropic medication.
Open Versus Percutaneous Insertion of CAPD Catheters

Healthy kidneys clean your blood by removing excess fluid, minerals, and wastes. When your kidneys fail, harmful wastes build up in your body and your body may retain excess fluid. When this happens, you need treatment to replace the work of your failed kidneys. This may be with a dialysis machine using haemodialysis or with fluid in the abdomen or peritoneal dialysis.

In peritoneal dialysis, a tube called a catheter is put in the abdomen wall and used to fill your abdomen with a cleansing liquid called dialysis solution. The walls of your abdominal cavity are lined with a membrane called the peritoneum, which allows waste products and extra fluid to pass from your blood into the dialysis solution. These wastes and fluid are removed from the body when the dialysis fluid is drained and replaced with a fresh solution.

The tubes or catheters used to exchange the fluid are currently positioned using a general anaesthetic (with the patient awake) and an operation with a cut under the belly button. Newer techniques using local anaesthetic (with the patient awake and the area numbed) and requiring only a small cut in the skin have been used. No one has ever directly compared the two techniques.

The investigators aim is to perform a direct comparison between the two techniques to look at the complications and time required for surgery and length of hospital stay required. The investigators will also look at the patients satisfaction and pain scores with each technique to help gather evidence as to which is likely to be the best technique to use from now on.


Eligibility Criteria:
Potential participating patients will be identified by referral to the vascular surgery department for insertion of CAPD catheter for peritoneal access.

Specific inclusion criteria necessary for invitation to study participation;

* Patients referred to vascular consultants for CAPD catheter insertion

General inclusion criteria:

* Ability to give informed written consent

Specific exclusion criteria:

* Previous abdominal surgery via midline incision
* Unfit for general anaesthetic
* Aged under 18 at time of referral

General exclusion criteria:

* Inability to give informed written consent
* Inability to attend follow up appointments

Withdrawal criteria:

* Patient request
* Patient non compliance with study protocol
Retrospective Evaluation of CML Patients in the National Compassionate Program

This observational study aims at assessing the tolerability and safety profiles of Ponatinib, a drug used for Chronic Myeloid Leukemia patients who are Philadelphia positive. This drug is used during the chronic phase of the disease, according to the Italian national compassionate law 648/96.

This observational study aims at assessing the tolerability and safety profiles of Ponatinib, a drug used for Chronic Myeloid Leukemia patients who are Philadelphia positive. This drug is used during the chronic phase of the disease, according to the Italian national compassionate law 648/96.

Eligibility Criteria:
Inclusion Criteria:

* CML Ph+ patients in chronic phase
* 18 years old or older
* Patients have received either Dasatinib or Nilotinib and resulted resistant or not tolerant to the drugs or have developed the T3151 mutation
* Patients have started Ponatinib at least 12 months before registration
* Informed consent signed at registration

Exclusion Criteria:

* CML Ph+ patients in accelerated or blast phase with acute lymphoblastic leukemia
Total Marrow Irradiation and High-dose Melphalan for Double Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma

The purpose of this study is to evaluate if the use total marrow irradiation (TMI) as a sole preparation for the first autologous hematopoietic stem cell transplantation (autoHSCT) followed by high-dose melphalan used prior to second autoHSCT is safe and effective in patients with multiple myeloma (MM).

AutoHSCT is a standard treatment of patients with MM. According to soem clinical evidence double autoHSCT provides survival advantage compared to a single procedure. Most frequently used conditioning regimen consists pf high doses of melphalan (HD-MEL). In some studies it was used in combination with total body irradiation (TBI), which, however was associated with significant toxicity. In our center the standard procedure includes TBI as a single treatment at 1st autoHSCT and HD-Mel at 2nd autoHSCT.

As in MM malignant plasma cells are localized almost exclusively in bone marrow there is rationale to limit irradiation to bones. For this purpose in the current study we substitute TBI with TMI. Additional boosts are provided for active sites of disease based on PET/CT imaging. Our intention is to minimize toxicity while maintaining the treatment efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Diagnosis of multiple myeloma
* PR, VGPR or CR at inclusion
* Performance status WHO 0-1
* Written informed consent

Exclusion Criteria:

* Organ dysfunction: elevated ALT, AST, bilirubin, AF; creatinine \>1.5 upper normal limit; LVEF \<45%
* Active infection
* Unstable diabetes
* Psychiatric diseases
* History of high-dose chemotherapy or irradiation
* Second malignancy
* Pregnancy
A Study to Evaluate the Impact of Escitalopram on Quality of Life and Social Functionality in Patients With Major Depressive Disorder With Anxiety Symptom

The purpose of this study is to evaluate the impact of escitalopram on quality of life and social functionality in patients with major depressive disorder with anxiety symptom.

This is an open-label (all people know the identity of the intervention), multi-center, prospective (a study in which the participants are identified and then followed forward in time for the outcome of the study), single-arm (all participants receiving one intervention) study. Approximately 260 participants will be enrolled in this study. This study consists of two phases: screening phase and treatment phase. In the treatment phase, participants will receive escitalopram for 8 weeks: escitalopram 10 mg per day for 1 week and then the dose of escitalopram will be flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment. Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be monitored throughout the study. The total study duration will be approximately 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depressive disorder according to the American Psychiatric Association's Diagnostic and Statistical Manual-IV, Text Revision (DSM-IV-TR) diagnostic criteria
* Minimum scores of 9 on Sheehan Disability Scale
* Minimum scores of 14 on Hamilton Anxiety Scale

Exclusion Criteria:

* History of primary or comorbid diagnoses of schizophrenia, schizoaffective disorder, bipolar disorder, or dementia
* Presence of unstable serious illness and/or has a clinically significant renal or hepatic impairment, seizure disorders or any other disease which may be detrimental to the participant or the study
* Participant who have continuously taken psychoactive substances, antidepressants, anxiolytics, Monoamine oxidase inhibitors, psychoactive herbal remedies, lithium, electroconvulsive therapy, carbamazepine in the past 2 weeks before the baseline visit
* Diagnosis of major depressive disorder who currently require treatment systematically within past 2 months from baseline
* Receiving pharmacological treatment, which is disallowed in the current approved Chinese summary of product characteristics for escitalopram
PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm

The primary objective is to evaluate the safety and effectiveness of surgeon modified endografts for the treatment of pararenal and thoracoabdominal aortic pathology in patients who are not candidate for traditional open repair due to comorbid issues and their anatomy is not amenable to commercially available endografts.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Male or female, aged ≥18 years
3. Expected survival beyond 1 year following successful aneurysm repair
4. Anatomy that would require coverage of the celiac artery, superior mesenteric artery (SMA), and/or renal arteries if conventional, FDA-approved endograft were implanted to obtain adequate sealing zone length
5. Aneurysm of the thoracoabdominal or pararenal aorta with or without chronic dissection
6. Adequate proximal zone of fixation
7. Adequate distal zone of fixation
8. No more than 5 non-aneurysmal visceral (celiac, SMA, or renal) arteries with diameters between 4-12mm
9. Adequate arterial access for delivery system; use of iliac conduit is permitted as necessary

Exclusion Criteria:

1. Moderate-to-severe aortic neck calcification, thrombus, or tortuosity
2. Severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit
3. Proximal landing within zone 0 or 1
4. Inability to maintain at least one patent hypogastric artery
5. Freely ruptured aneurysm with hemodynamic instability
6. Non-ambulatory status
7. Severe CHF
8. Baseline eGFR \< 30ml/min, unless currently on or to be initiating dialysis
9. Unstable angina
10. Stroke or MI within 3 months of planned treatment date
11. Active systemic infection and/or mycotic aneurysm
12. Uncorrectable coagulopathy or other bleeding diathesis
13. Known allergy to device material or contrast material that cannot be adequately pre-medicated
14. Body habitus that would preclude adequate fluoroscopic visualization of aorta
15. Pregnancy or lactation (confirmed per standard of care surgical practice)
16. Major, unrelated surgical procedure planned ≤30 days from endovascular repair
17. Patient is ≤30 days beyond primary endpoint for another investigative clinical drug/device trial
18. Social or psychological issues that would interfere with ability to comply with all study procedures for the duration of the study
19. Can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device
20. Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution
Ophthalmological Emergencies and COVID-19 Pandemia

To analyze how the COVID 19 pandemia has affected the patient's accesses to the Ophthalmological Emergency Department of a tertiary referral center in northern Italy, during the lockdown period. We will collect data from different periods in 2020, in which the Italian Governement called the total lockdown to same periods of the 2019. The charts of all patients will be evaluated to analyze demographics and clinical data

Since the end of 2019, an outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), originating in the Chinese city of Wuhan has spread rapidly worldwide causing thousands of deaths. Coronavirus disease (COVID-19) is supported by SARS-CoV-2 and represents the causative agent of a potentially fatal disease that is of great global public health concern. Italy has been the first European country recording an elevated number of infected forcing the Italian Government to call for total lockdown. The lockdown had the aim to limit the spread of infection through social distancing. The purpose of this study is to analyze how the pandemic has affected the patient's accesses to the Ophthalmological Emergency Department of a tertiary referral center in northern Italy, during the lockdown period. The charts of all patients that came to the Emergency Department during the lockdown period (February -May, 2020 and October - December 2020) will be retrospectively collected and compared with those in the same periods of 2019 .

All demographics and clinical data will be analyzed and compared to evaluate differences and type of accesses.

Eligibility Criteria:
Inclusion Criteria:

Access to emergency room in the definite periods Completed Patients Charts -

Exclusion Criteria:

Access to emergency room in other periods Demographics and clinical data not completed

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Collaborative Studies on the Genetics of Asthma (CSGA)

To conduct molecular genetic studies in human pedigrees in order to identify the major genes responsible for asthma.

BACKGROUND:

Asthma is a respiratory disease characterized by variable airways obstruction, airways inflammation and bronchial hyperresponsiveness (BHR). There are recent increases in asthma mortality and prevalence in the US, especially in African-Americans. Multiple studies suggest that both genetic and environmental factors are important in asthma susceptibility.

The study was recommended by the Pulmonary Diseases Advisory Committee at its February 1991 meeting and given concept approval by the May 1991 National Heart, Lung, and Blood Advisory Council. The Request for Applications was released in October 1992.

DESIGN NARRATIVE:

The CSGA was composed of five centers (Johns Hopkins University, University of Chicago, University of Maryland, University of Minnesota, and a data coordinating center at Wake Forest). At each center, families were ascertained through two siblings with asthma. All family members were characterized with spirometry, bronchial responsiveness to methacholine or reversibility testing, skin-tests and questionnaire data. The initial genome screen was completed on the first 237 sib pairs from three racial groups (African-American, Caucasian and Hispanic), and genotyping on the remaining family members and families was completed before the study was renewed in 1997. Therefore, the initial aim of the CSGA to map susceptibility regions was completed, with detection of several novel chromosomal regions, and replication of several regions previously linked to associated phenotypes.

In order to determine the importance of these regions in asthma susceptibility and the impact of environmental rink factors, the investigators l) evaluated the evidence for linkage in the complete CSGA data using 2-point, multipoint and multilocus approaches for asthma and associated phenotypes (including BHR, total serum IgE and skin test reactivity to standardized allergens); 2) performed fine mapping studies of regions using additional genetic markers to obtain a \< 2 cM map; 3) identified candidate genes and novel sequence variants; and 4) characterized a patient population with asthma to study identified variants with respect to asthma severity and bronchial inflammation. These studies allowed identification of asthma susceptibility genes and their variants, interactions with other genes and environmental risk factors, as well as provided insight for the development of improved treatment and ultimate prevention of asthma.

Eligibility Criteria:
No eligibility criteria