cyrilzakka/clinical-trials huggingface dataset:
Development of a National Protocol for Stroke Rehabilitation in a Multicenter Italian Institution

Due to the importance to use standardized shared protocols in the rehabilitative setting of cerebrovascular diseases, an harmonization and redefinition of the Don Carlo Gnocchi Foundation rehabilitative model was carried out. Such process was in line with the Evidence Based approach of Cochrane Rehabilitation.

Despite progress in the treatment of cerebrovascular diseases in the acute phase, stroke remains a catastrophic event with important public health consequences. According to the most recent ASA/AHA guidelines, a specific and intensive rehabilitation is recommended in patients with neurological impairments after stroke in the postacute phase.

In this regard, the use of standardized shared evaluation protocols, developed according to the ICF model is strongly recommended to evaluate the effectiveness of rehabilitative treatments on large populations of stroke patients affected and, possibly, to allow the identification of biomarkers, identifiable in the acute phase and in the immediate post-acute period, to predict prognosis and to orient rehabilitation care.

The Don Carlo Gnocchi Foundation ONLUS is one of the most important health groups in Italy, with over 3,700 beds and 28 Centers, active in 9 Italian regions (Northern, Central and Southern Italy). The don Gnocchi Rehabilitation Hospitals are accredited by the different Regional Health Services all over Italy.

During 2016 and based on 60 years of experience, an harmonization and redefinition of the Foundation rehabilitative model was carried out. Such process was in line with the Evidence Based approach of Cochrane Rehabilitation.

The Medical Committee was the first step for the national identification of a group of health professionals which includes, in addition to MD specialists, all health professions involved in Interdisciplinary Rehabilitation Team.

The first objective was to develop consensus over national Rehabilitation protocols for the most prevalent conditions addressed to in our Rehabilitation Hospitals. Given the prevalence of neurological rehabilitation treatments and in particular Stroke, the Medical Direction appointed a group of 6 Specialists, who entrusted the task of developing a Stroke rehabilitation don Gnocchi Protocol.

The study describes the method and the criteria used in the development of the protocol, the steps followed in its implementation in two Don Gnocchi Foundation Pilot Hospitals, and the preliminary results of the pilot study, limited to the treatment of intensive post-acute inpatient rehabilitation, with the objective of verifying the feasibility of the protocol and comparing the outcomes for stroke inpatient rehabilitation with those of the 3 years prior to implementation.

Eligibility Criteria:
Inclusion Criteria:

* age 18-90;
* acute ischemic or hermorragic stroke (within 30 days);
* consent both to participate and to anonymous data processing.

Exclusion Criteria:

* stroke occured more than 30 days after the transfer to intensive rehabilitation;
* patient's refusal to participate in the study.
Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients

The objective of CAREBANK study is to establish definitive relationships with human cardiac samples and clinical phenotypes in patients undergoing cardiac procedures. Specifically, the investigators aim at comparing atrial phenotypes from atrial fibrillation patients and controls. The work consists of three broad categories: A) role of atrial cardiomyopathy in atrial fibrillation; B) genetic defects predisposing to atrial fibrillation; and C) the role of inflammation in atrial fibrillation.

The investigators aim to A) compare atrial cardiomyopathy findings from the tissue samples to clinical phenotype and adverse events B) study the association of genetic defects predisposing to atrial fibrillation with atrial cardiomyopathy findings in the tissue samples C) assess the role of inflammation in atrial fibrillation by comparing circulating cytokine profiles, purinergic signaling and atrial cardiomyopathy findings in tissue samples.

Eligibility Criteria:
Inclusion Criteria:

* Any open-heart cardiac surgery
* Written informed consent
* All-comers design

Exclusion Criteria:

* No informed consent
Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With RHF Caused by PAH

Efficacy and safety evaluation of tolvaptan in the treatment of patients with right heart failure caused by pulmonary arterial hypertension

The study is a prospective, single-center, randomized controlled trial. Specifically, the research focuses on patients with right heart failure due to PAH in the Pulmonary Vascular Ward of Fuwai Hospital. Within 12 hours of admission, subjects were randomly assigned to two groups using the central randomization method. The dose of tolvaptan (15 mg/d) is added to standard therapy (including diuretics) for subjects in group A. Traditional standard therapy (including diuretics) is used for subjects in group B. The treatment lasts for a total of seven days to assess the efficacy and safety of tolvaptan in the treatment of PAH-induced right heart failure. An informed consent form must be signed by each participant in our study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have no serious cerebrovascular, liver, kidney and lung organ and tissue diseases.
* No corticosteroids or immunosuppressive agents had been administered to the - Patients in the three months prior to enrollment in the study.
* Patients voluntarily participated in the study and signed an informed consent form.

Exclusion Criteria:

* Patients who install the circulation aids.
* Patients who have been diagnosed with active myocarditis or amyloid cardiomyopathy.
* Fasting blood glucose level exceeded 12.21 mmol/L in individuals with uncontrolled diabetes.
* Patients who suffer from anuria, urethral strictures, stones, or tumors caused by urination disorders.
* Patients with acute myocardial infarctions, persistent ventricular tachycardias, or ventricular fibrillations, and cerebrovascular accidents within the first 30 days of the screening period.
* Patients with a history of allergy or specific reactions to benzodiazepines. (Mozavaputan hydrochloride, Benaepril hydrochloride)
* Any of the following laboratory tests were abnormal: serum creatinine\> 2.5 times the upper normal value limit, serum sodium\> 145 mmol/L, and serum potassium\> 5.5 mmol/L.
* Pregnant women, lactating women, or patients who may be pregnant or have pregnancy plans.
* Patients with other contraindications to the use of tolvaptan.
* Patients who have been taking tolvaptan within the first 3 months before inclusion in the study, either when the drug was marketed or when it was being clinically studied.
* Additionally, patients who were judged by the investigators not fit to be enrolled in this trial.
Computer-based Self-Help Program for People With Gambling Problems

The study examines the effectiveness of a computer-based self-help-program for individuals with problematic or pathological gambling behavior.The main objective of the study is to investigate the extent to which the online program leads to a significant reduction in pathological gambling (primary outcome), depression and gambling-specific dysfunctional thoughts. The program is expected to lead to a significant reduction regarding all measures when compared to a control group. The study is conducted as a randomized-controlled trial with one intervention group and one wait-list control group.

The study examines the effectiveness of a computer-based self-help-program for individuals with problematic and pathological gambling behavior. The main objective of the study is to investigate the extent to which the online program leads to a significant reduction in pathological gambling. The primary outcome is the PG-Y-BOCS as a measure of the severity of pathological gambling symptoms. Secondary outcomes are rates of depression, measured with the PHQ-9 as well as gambling-specific cognitive biases, measured with the GABS. The program is expected to lead to a significant reduction in problematic/pathological gambling behavior (PG-Y-BOCS) and also to declines in both depressive symptoms (PHQ-9) and gambling-specific cognitive biases (GABS). The study is conducted as a randomized-controlled trial with one intervention group and one wait-list control group. The intervention group receives the login data directly following the baseline survey and can use the program over a period of 8 weeks, whereas the wait-list control group receives access to the program after completion of the post-survey.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* access to internet
* adequate usage of German language
* willingness to participate in two short (25-30 minutes) online surveys
* willingness to use the online program over a period of 8 weeks (participants that do not use the program are also included in the analysis)
* willingness to leave an (anonymous) email-address
* existence of the wish to receive treatment

Exclusion Criteria:

* existence of a lifetime diagnosis of schizophrenia or bipolar disorder
* existence of an acute suicidal tendency (assessed with item 9 of the PHQ-9, ≥3)
Implementation and Evaluation of a Pediatric Nurse-driven Sedation Protocol in a PICU

Management of analgesia and sedation is an integral component of the medical care of a critically-ill child. Its role is to assure comfort and safety to a patient undergoing painful cares and technical procedures; it can also be, in particular situations like acute respiratory distress syndrome or acute brain injury, a full processing treatment.

Sedation involves, most of the time, the association of an opioid and a sedative. The use of these drugs is difficult in children, because of a specific metabolism, inducing tolerance and withdrawal in case of prolonged administration.

The COMFORT-BEHAVIOR (COMFORT-B) scale is a validated, simple, reliable and reproducible score evaluating sedation and analgesia. Sedation scoring systems must be used regularly to avoid inadequate sedation.

Excessive sedation is associated with poor outcomes like prolonged mechanical ventilation, longer hospitalisation and more frequent withdrawal symptoms. Adult and paediatric data suggest that goal-directed sedation algorithms allow a more appropriate adaptation of the treatment to the patient's need and permit a reduction in the duration of mechanical ventilation.

The objective was to evaluate the impact of a nurse-driven sedation protocol in a paediatric intensive care unit on duration of mechanical ventilation, total doses and duration of medications, Paediatric Intensive Care Unit (PICU) length of stay, incidence of ventilator-associated-pneumonia and occurrence of withdrawal.


Eligibility Criteria:
Inclusion Criteria:

* Mechanically-ventilated patients aged from 0 to 18 years receiving sedation for more than 24 hours

Exclusion Criteria:

* Patients with tracheostomy
The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.

It is intended to examine the safety and efficacy of desensitization therapy by GB-0998 (intravenous immunoglobulin) for the anti-donor antibody positive recipient in need of pre-transplant desensitization. Patients with positive FCXM-T after performing twice double filtration plasmapheresis (DFPP) therapy will receive GB-0998 1g/kg/day for four days.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stage 4 or 5 on the CKD classification.
* Of the patients that wants a living-donor kidney transplant of ABO blood type compatible, patients with positive FCXM-T and negative CDC-T to the donor.
* Patients with positive FCXM-T after performing twice DFPP therapy

Exclusion Criteria:

* Patients who had taking to continue immunosuppressive drugs or steroids within 4 weeks before obtaining informed consent.
* Patients who had IVIG therapy, or plasmapheresis therapy within 12 weeks before to informed consent.
* Patients who had Rituximab within 6 month before to informed consent.
* Patients who have undergone splenectomy.
* Patients with severe hepatic disorder or severe heart disorder.
* Patients with receiving treatment of malignancy.
* Patients with high risk of thromboembolism.
* Patients with history of shock or hypersensitivity to GB-0998.
* Patients with hereditary fructose intolerance or IgA deficiency.
* Patients with pregnant or probably pregnant.
Study to Evaluate the Response Rate to the Licensed Pneumovax 23™ in Elderly Population.

Streptococcus pneumoniae are bacteria which normally live in the upper respiratory tract of humans. However, these bacteria can also cause severe infectious diseases such as pneumonia, septicemia and meningitis. Elderly subjects are especially vulnerable to these infections, and the diseases can result in death. The currently available licensed Streptococcus pneumoniae vaccine is recommended for prevention of pneumococcal diseases in individuals over the age of 65. However, the antibody level elicited by this vaccine, is not always satisfactory in elderly people. To overcome the problem, GlaxoSmithKline Biologicals is currently developing candidate vaccines that are hoped to work better than the currently available vaccines. As a first step in this development, the present study is being conducted in order to evaluate the immune response to the currently marketed vaccine.

Since influenza vaccination is recommended in the age range of the study population, Fluarix™ (GlaxoSmithKline Biologicals) vaccine will be offered free of charge for the study period (3 consecutive years), to be used by Investigators according to national vaccination schedule/practice.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Eligibility Criteria:
Inclusion criteria

* Subjects who the investigator believes will comply with the requirements of the protocol.
* A male or female \>= 65 years at the time of the first vaccination.
* Written informed consent obtained from the subject.

Exclusion criteria

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
* Previous vaccination against Streptococcus pneumoniae.
* History of administration of an experimental vaccine containing MPL or QS21.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Planned administration of a vaccine not foreseen by the study protocol within 2 weeks before and after first dose of vaccines, excluding influenza vaccine which can be administered at any time, including co-administration with Pneumovax23™.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* Current serious neurologic or mental disorders.
* Inflammatory processes such as known chronic active infections (e.g.Hep B, C).
* All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
* Acute disease at the time of enrolment.
* Chronic disease that might preclude participation to the whole study.
Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot

Researchers are trying to learn more about the prevalence of genetic mutations in women who are at intermediate/high risk of breast cancer and how that information my assist providers in improving screening and preventative options.


Eligibility Criteria:
Inclusion Criteria:

* Women participating in IRB:18-010601
* Aged 35 and over with a negative routine mammogram within 3 months.
* Qualifies as intermediate or high-risk (\>15% lifetime risk of breast cancer as defined by IBIS version 8).
* Have an active email address for survey completion

Exclusion Criteria:

* Not participating in the Mayo Clinic CEDM pilot (IRB: 18-010601)
* Known genetic cancer syndrome with test results available for review in Mayo EMR
* Known breast cancer
* Unable to understand or sign informed consent
Association of Ferritin Levels With Clinical Parameters in Patients With Fibromyalgia Syndrome

The aim of the present study was to evaluate the association between ferritin levels and clinical parameters in patients with fibromyalgia syndrome.

This sectional study included 100 patients with non-anemic FMS diagnosis and 100 patients with non anemic non FMS diagnosis whose ferritin levels were measured within the last four weeks. The participants were evaluated using Fibromyalgia Impact Questionnaire (FIQ), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI) and Pittsburg Sleep Quality Index (PSQI) as well as with a questionnaire form about descriptive characteristics. Serum ferritin level of \<30 ng/mL was considered iron deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgi syndrome patients
* ferritin levels were measured within the last four weeks

Exclusion Criteria:

* parenteral or enteral iron usage in last four weeks
* hemoglobin level was less than 12 g/dl
* infection
* malignity
* active inflammatory arthritis
* serious skin variations
* serious peripheral vascular disease
* iron storing disorder
* pregnant or lactating patients
Stem Cells and Stromal Vascular Fraction for Temporomandibular Joint Disease

It will be evaluate the safety of mesenchymal stem cells and adipose tissue derived stromal vascular fraction (SVF) in temporomandibular joint disease cases.

umbilical cord derived mesenchymal stem cells produced under GMP facility in Erciyes University and SVF produced in operation theatre.

Eligibility Criteria:
Inclusion Criteria:

* Chronic temporomandibular arthritic disorder
* History of pain and joint noises for at least 3 months
* Must have more than VAS 5 TMJ pain
* must have internal derangement of TMJ
* Limited mouth opening
* Magnetic resonance imaging evidence of effusion or degeneration
* Already treated with conservative methods (occlusal splint,pharmacological and/or physio-kinesio therapy) without satisfactory benefit.

Exclusion Criteria:

* Cancer patients
* Immunosupressed patients
* Previous TMJ traumas and fractures
* Previous TMJ surgeries
* TMJ ankylosis
A Comparative Study Between Three Different Plating Techniques in Management of Mandibular Parasymphyseal Fractures.

The main goal in management of mandibular fractures is to restore the pre-injury form and function, with the least disability and shortest recovery period.

Currently there are a diversity of metallic hardware used for fixation of jaw fractures. However, the proper selection of the suitable technique is still a matter of debate.

The aim of the current study was to compare between the effect of two miniplates, 2.3 high profile Miniplates and three dimensional (3D) Miniplates for internal fixation treatment of mandibular para-symphyseal fractures.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with symphyseal/ parasymphyseal mandibular fracture.
2. Patients presenting within 7 days of trauma.

Exclusion Criteria:

1. Associated fractures that could affect occlusion or dimensions
2. Medically compromised patients who are unfit for management under General Anesthesia
3. Patients with gross infection at the site of fracture
4. Patients not willing to return for follow-up
5. Patients with associated bone pathology
Comparison of Fiberoptic Bronchoscopic Intubation Between Silicone and Polyvinylchloride Double Lumen Tube.

One lung ventilation (OLV) is required during thoracic procedure such as lung and esophagus surgery, and carried out by double lumen tube(DLT). Direct insertion of DLT over a fibreoptic bronchoscope (FOB) is considered more difficult and traumatic than that of a single-lumen tube. Recently, One recent simulation study demonstrated that a soft silicone DLT with a flexible, wire-reinforced bronchial tip (Fuji-Phycon tube) may shorten the time to intubation via tube exchange when compared with less compliant, polyvinyochloride(PVC) DLTs such as the Shilly or Rusch DLT. HumanBroncho® (Insung Medical, Seoul, Korea) is a new silicone DLT with a soft, flexible, non-bevelled, wire-reinforced tip. The oval shape, obtuse angle, and short lateral internal diameter of the bronchial lumen and its flexibility may allow for advancement to the trachea over the FOB easier than the Shilly tube.

In the present study, The investigators aimed to test the hypothesis that the silicone DLT would be easier than PVC DLT with regard to railroading grade over an FOB. Investigators further aimed to compare the intubation time over the FOB between the silicone DLT and PVC DLT.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing thoracic surgery and one lung ventilation American Society of Anesthesiologist physical status 1,2

Exclusion Criteria:

* abnormal upper airway, gastrointestinal disease, risk of aspiration, BMI \> 35
A Study Of Glasdegib In Healthy Volunteers To Establish The Bioequivalence Of The Phase 2 Formulation To The ICH Formulation

This study is intended to establish the bioequivalence (BE) of single 100 mg doses of glasdegib administered under fasted conditions to healthy volunteers as the ICH formulation compared to the Phase 2 formulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non-child bearing potential who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests. Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:

  1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 24 consecutive months with no alternative pathological or physiological cause; with a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;
  2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
  3. Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) are considered to be of childbearing potential.
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. -. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* A positive urine drug test.
* Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval \>450 msec or a QRS interval \>120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the subject's eligibility.
* Subjects with family history of myocardial infarction, congenital long QT syndrome, torsades de pointes or clinically significant ventricular arrhythmias. Subjects should be within normal range of potassium, magnesium and corrected calcium calculation at screening.
* Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential; male subjects with partners currently pregnant; male subjects who are unwilling or unable to use two highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 90 days after the last dose of investigational product and, refrain from sperm donation for the duration of the Study and for at least 90 days after the last dose of investigational product.