cyrilzakka/clinical-trials huggingface dataset:
Preventable Paediatric Trauma - Retrospective Analysis

Purpose: a retrospective study of all Paediatric patients who presented to Ziv Medical Centre with injuries of all systems, major and minor, in order to determine the exact circumstances of the injury, whether this might have been preventable and design a Haddon Matrix of risk factors for injury to target prevention.

Hypothesis: injury prevention interventions can be targetted by finding out local causes of Paediatric Trauma

A Trauma Registry is already kept in the hospital. It is confidential and data is supplied to the government from this registry.

The procedure is to be granted access to the database and access data stored on the mechanism and outcome of Paeditric Trauma. This data will be stored on the work computer of the principal investigator and will be password protected.

Methods: Identify from the Trauma database all patients assessed at Ziv Medical Centre with Trauma, consult their medical notes and document the exact injury, the mechanism of injury, the circumstances, whether the child was alone or supervised, the nature and complications of the injury, treatment required and short and long term progress and disability.

Eligibility Criteria:
Inclusion Criteria:

* All patients classified as Paediatric according to Israeli law (up to the age of 18 years). This includes pregnant women and patients presenting with multiple complaints as well as Trauma, isolated injuries and polytrauma.

Exclusion Criteria:

* Patients for whom no history is available.
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and Caucasian Participants

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of single and multiple oral doses of GDC-0853 in healthy Japanese and Caucasian subjects.

This study will be a randomized, placebo-controlled, double-blind, single and multiple dose study. Approximately 32 healthy subjects will be enrolled in 4 discrete cohorts with 8 subjects per cohort.

Eligibility Criteria:
Inclusion Criteria:

* Japanese subjects must have both Japanese parents and all grandparents who were born in a Japanese country of origin
* Caucasian subjects must have 4 Caucasian grandparents (Hispanics of white race can be considered Caucasians)
* Within body mass index range of 18 to 31 kilograms per square meter, inclusive
* Females will be non-pregnant, non-lactating, and either postmenopausal or surgically sterile
* Males will either be sterile or agree to use an approved method of contraception

Exclusion Criteria:

* Significant history or clinical manifestation of any significant metabolic, allergic/immunologic/immunodeficiency, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the investigator)
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
* Participation in any other investigational study drug trial in which receipt of any investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to check in
* History of malignancy, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma with 3-year disease-free follow up
* Any acute or chronic condition or any other reason that, in the opinion of the investigator, would limit the participant's ability to complete and/or participate in this clinical study
Effectiveness of Cortiment® in Patients With Ulcerative Colitis

The purpose of this study is to evaluate Cortiment® with regard to its use by clinicians in routine clinical practice and its effectiveness and tolerability in a real-life setting.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥ 18 years
* Outpatients
* Patients who have been prescribed Cortiment® for the treatment of mild to moderate active ulcerative colitis within a 5 days' time window prior to being included in the study
* Patients who have received adequate information regarding this non-interventional study and are able to understand and voluntarily sign the Informed Consent

Exclusion Criteria:

* Patients with severe active / fulminant ulcerative colitis
* Patients treated with antibiotics or corticosteroids for the current flare. Use of Antibiotics for other conditions non-related to the gastrointestinal tract, either before enrolment or during the observational period is permitted.
* History of total / sub-total colectomy
* Hypersensitivity to the active substance, lecithin (derived soya oil, peanut oil) or to any of the excipients
* Patients enrolled and involved in an interventional study
* Patients whom investigators consider inappropriate to participate in the study
Open-Label Extension of the PTI-125-04 Study in Mild-to-Moderate Alzheimer's Disease

This is a 96-week extension study of open-label simufilam 100 mg b.i.d. for mild-to-moderate Alzheimer's disease subjects who completed the Phase 2 study, PTI-125-04. The study will evaluate safety and long-term treatment. Safety will be assessed by AE monitoring, clinical labs, urinalysis, vital signs, ECGs, and C-SSRS.

This is an open-label 96-week extension study of open-label simufilam 100 mg b.i.d. for subjects who completed the Phase 2 study, PTI-125-04. All subjects will provide consent to enroll into this study. Simufilam will be administered as coated oral tablets. The last study visit, Month 24, from the PTI-125-04 study will be used for the Study Day 1 visit assessments in this extension study. Clinic visits will occur every 12 weeks ±10 days. A complete physical examination will be performed at Study Day 1, Week 48 and Week 96. Subjects will return to the clinic every 12 weeks for safety assessments of vital signs, AE monitoring, C-SSRS, and drug dispensation and accountability. Blood draws for clinical laboratory testing, urine collection for urinalysis, and ECGs will be performed at Study Day 1 and Weeks 24, 48, 72, and 96. Safety will be evaluated by adverse event monitoring, vital signs, clinical labs, and the Columbia Suicide Severity Rating Scale (C-SSRS).

Eligibility Criteria:
• Subjects must have completed the PTI-125-04 study.
Reforça't: a Community, Social, and Healthcare Program for Patients with Cardiorespiratory Conditions Upon Hospital Discharge

The goal of this randomized clinical trial is to determine whether an interdisciplinary, community-based intervention can reduce 30-day hospital readmissions and improve functional outcomes in patients aged 65 or older with chronic cardiac, respiratory, or mixed conditions following hospital discharge.

The main questions it aims to answer are:

Can the Reforça't program reduce 30-day hospital readmission rates to 25% compared to standard care? Does participation in Reforça't improve functional outcomes, medication adherence, quality of life, and mortality rates in this patient population?

Researchers will compare patients enrolled in Reforça't (intervention group) with those receiving standard care (control group) to determine whether the program leads to lower readmission rates, improved health outcomes, and higher cost-effectiveness.

Participants will:

Undergo a pre- and post-intervention assessment (30 days post-discharge). Receive comprehensive, interdisciplinary care integrating medical, social, and rehabilitation services.

Be monitored for 12 months to assess readmissions, survival, nursing home admissions, and overall well-being.


Eligibility Criteria:
Inclusion Criteria:

* Users admitted to the Polivalent Observation Units, Internal Medicine, or Hospital at home.
* Individuals aged 65 years or older.
* Hospital admission due to decompensation of a cardiac, respiratory, or mixed condition.
* Place of residence within the health coverage area of Sant Jaume de Calella Hospital - Corporació de Salut del Maresme i la Selva.
* Willingness to participate in the study as gathered by the signing of an informed consent document

Exclusion Criteria:

* Users institutionalized in a nursing home
* Users already enrolled in home care programs
* Users in the Advanced Chronic Care Model program with a limited life prognosis
* Users on the waiting list for organ transplantation
* Users with language barriers
* Users with a GDS (Global Deterioration Scale) score of 5 or higher
* Users who have already been included in the Reforça't program
Gene Therapy for DME

The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with Diabetic Macular Edema (DME). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.


Eligibility Criteria:
Inclusion Criteria:

* Subjects that are willing and able to follow study procedures;
* Female or male patients 18-74 years old at the time of signing the ICF;
* Clinically diagnosed with CI-DME;
* The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters;

Exclusion Criteria:

* Presence of any other intraocular diseases other than DME in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.
The Number and Function of Regular T Cell in Patients With Obstructive Sleep Apnea

To compare the number and function of regular T cell of patients with obstructive sleep apnea (OSA) versus that of age-, gender- and BMI (body mass index)-matched controls

Patients with obstructive sleep apnea (OSA) experience intermittent hypoxemia and arousal during sleep due to recurrent collapse of upper airway. Epidemiologic evidence showed they were at higher risk for autoimmune diseases. The regular T cell (Treg) has a crucial role in controlling autoimmunity. In this study, 40 OSA patients and 40 age-, gender- and BMI-matched controls will be recruited. Peripheral venous blood of the participants is drawn for numeration of CD4+CD25+FoxP3+ regular T cells by flow cytometry. As well, the CD4+CD25+ regular T cells are enriched by MACS and tested for their suppressive functions on proliferation assays. Th12+ CD4+ cells are also measured.

Eligibility Criteria:
Inclusion Criteria:

1. OSA patients diagnosed with a polysomnography
2. Agree to participate the study and sign informed consent

Exclusion Criteria:

1. Do not agree to participate the study and sign informed consent
2. Has received any treatment or OSA
3. With major comorbidities (such as a diabetes, heart disease, lung diseases, renal diseases, autoimmune diseases, but hypertension excluded)
4. History of sarcoidosis and tuberculosis
5. On treatment of steroid and immunosuppressant
Glycemic and Insulinemic Impact of Selected Canadian Beans

The objective of this study is to compare the glycemic and insulinemic response elicited by ½ cup servings of 6 beans to those elicited by ½ cup servings of mashed potato, macaroni, rice and corn.

In order for a food to be able to claim a reduced glycemic response, it must be shown that a typical serving of the food elicits a significantly lower blood glucose responses compared to a serving of an appropriate control food. While many studies have examined the GI of beans, few studies have compared the glycemic impact of a typical serving of beans to a typical serving of other starchy foods. Therefore, there are insufficient data to allow for a claim that beans have a low glycemic response. In addition, in order to make a claim of a reduced glycemic response, regulatory agencies also require that the insulinemic response to a food is not disproportionately increased.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant females, 18-75 years of age, inclusive
* Body mass index (BMI) \< 40 kg/m²
* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and to refrain from smoking for 12hr prior to each visit.
* Normal fasting serum glucose (\<7.0mmol/L capillary corresponding to whole blood glucose \<6.3mmol/L).
* Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.

Exclusion Criteria:

* Failure to meet any one of the inclusion criteria
* Known history of AIDS, hepatitis, diabetes or a heart condition
* Subjects using medications or with any condition which might, in the opinion of Dr. Wolever, the Medical Director of GI Labs, either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
* Major trauma or surgical event within 3 months of screening.
* Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
* Known intolerance, sensitivity or allergy to any ingredients in the study products.
Evaluation of Pneumococcal Vaccine Coverage

Pneumococcal infections are frequent and serious. Streptococcus pneumoniae is the leading cause of community-acquired pneumonia in adults. In metropolitan France, there are 6000 to 7000 bacteremic pneumococcal infections each year, with a mortality rate of 10 to 30% in adults.

To fight against these bacterial infections, vaccines have been developed. At a time when antibiotic savings and the fight against antimicrobial resistance are major public health issues, vaccination is a first choice option to slow the development of pneumococcal resistance. Thus, after these different actions, the proportions of pneumococci with decreased susceptibility to penicillin G fell from 53 to 22%.

While there is a significant decrease in invasive pneumococcal disease in children since the use of conjugate vaccines (vaccination of up to 94% of children), the rate of invasive Pneumococcal disease in adults has decreased less significantly.

In March 2017, the High Council of Public Health (HCSP) proposed the vaccination of all non-immunocompromised adults at risk and immunocompromised patients.

Awareness-raising among vaccinating physicians seems essential, especially in recent years when the value of vaccination is threatened by speculation about its efficacy and toxicity. However, the investigators know that vaccination aims not only to protect the individual, but also the population, especially children and the elderly and the fragile people.

Thus, in the context of pneumococcal vaccination, identifying one or more profiles of patients at risk in the absence of vaccination could be particularly beneficial. Indeed, if the physician knows about the population at risk of not being vaccinated, it will be better able to identify patients at risk of not being protected against pneumococcus.


Eligibility Criteria:
Inclusion Criteria:

* patient over the age of 18
* Patient without cognitive impairment
* Follow-up at the time of inclusion by a physician
* Patient with one or more indications for an anti-pneumococcal vaccination according to the 2017 vaccine recommendations
* Non-immunocompromised patients at risk, with underlying disease predisposing to the occurrence of invasive pneumococcal disease

Exclusion Criteria:

* Patient's opposition to participate
* Patients with the following contraindications to pneumococcal vaccination: severe acute infection in progress, allergy to one of the components vaccin
* Patient deprived of liberty
* Patient under guardianship
Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz SystemTMd

Establish a data repository of patients who have undergone thoracic and/or lumbar instrumented arthrodesis procedure supplemented by the Implanet Jazz System.

The purpose of this study is to create a data repository of patients who have undergone spinal arthrodesis procedures supplemented with the Implanet Jazz System. This device is designed to provide a stable interface between spinal constructs and the rods; it can be secured around vertebral structures (such as the lamina, transverse or spinous processes) from T1 to L5 and is intended to provide temporary stabilization as a bone anchor during the development of a solid bony fusion.

Patients who are candidates for hybrid thoracolumbar fixation with the Implanet Jazz System during arthrodesis surgery will be asked to participate in this protocol. Clinical data will be collected as indicated at 6 weeks, as well as 3, 6, 12, 24, 36 48, and 60 months post surgery in the database. Data collected will include demographic and surgical information, physiological data, neurological assessments and patient reported outcomes. This comprehensive database will allow for gathering of relevant information for potential future research use.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are candidates for spinal arthrodesis surgery (thoracic and/or lumbar) supplemented by the Implanet Jazz System are eligible to participate in this study.

Exclusion Criteria:

* Patients under the age of 18 are excluded because the investigators do not routinely perform spinal arthrodesis surgery on these patients.
Autologous Platelet Rich Plasma (PRP) Intra Ovarian Infusion in Perimenopausal Women

Autologous PRP intra ovarian infusion may improve ovarian response and women's hormonal profile and may promote folliculogenesis in perimenopausal women.

This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on improving ovarian tissue functionality and hormonal profile of perimenopausal women. PRP is blood plasma prepared from fresh whole blood that has been enriched with platelets. It is collected from peripheral veins and contains several growth factors such as vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), platelet derived growth factor (PDGF), transforming growth factor (TGF) and other cytokines all of which stimulate tissue proliferation and growth. PRP has been employed in several medical conditions in Orthopedics, Dermatology, and Ophthalmology for wound healing. It's efficacy in ovarian rejuvenation and reactivation and endometrial regeneration has not been fully elucidated. This study aims to investigate the effect of autologous PRP intra ovarian infusion on improving ovarian tissue functionality in perimenopausal women.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥40 years of age, presenting with cycle irregularities while fulfilling at least one of the respective two criteria: more than seven days difference in menstrual cycle duration between two consecutive cycles OR, presence of a menstrual cycle duration over sixty days and progressive elevation of FSH levels.
* Discontinuation of any complementary/adjuvant treatment including hormone replacement, acupuncture, and botanotherapy, for at least three months prior to recruitment.
* Willing to comply with study requirements

Exclusion Criteria:

* Any pathological disorder related to reproductive system anatomy
* Amenorrhea
* Endometriosis
* Adenomyosis
* Fibroids and adhesions
* Infections in reproductive system
* Current or previous diagnosis of cancer in reproductive system
* History of familiar cancer in reproductive system
* Severe male factor infertility
* Prior referral for PGT
* Ovarian inaccessibility
* Previous POI diagnosis -Endocrinological disorders (Hypothalamus-
* Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome)
* BMI\>30 kg/m2 or BMI\<18.5 kg/m2
* Systematic autoimmune disorders
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors

Late subclinical cardiovascular disease in testicular cancer survivors exposed to cisplatin-based chemotherapy and bone marrow transplant

Testicular cancer (TC) is diagnosed in young adult males between 18-39 years old. There are late (≥10 years after treatment) atherosclerotic cardiovascular disease (ASCVD) events after cisplatin-based chemotherapy (CBCT) treatment in testicular cancer survivors (TCS), along with heightened rates of hypertension, dyslipidemia, diabetes mellitus, and metabolic syndrome. Early detection of ASCVD to direct preventive measures in young TCS is an unmet need as these patients typically fall short of traditional 40-45-year age-cut offs for ASCVD screening. ASCVD risk will be evaluated in TCS ≥ 10 years after treatment in three groups: 1)TCS exposed to CBCT, 2)TCS exposed to CBCT and bone marrow transplant (BMT), and 3)TCS cured with surgical resection/surveillance. The focus will be on detecting subclinical atherosclerosis in TCS using blood lipid biomarkers and advanced cardiac CT imaging.

Eligibility Criteria:
Inclusion Criteria

* Patients \>18 years of age
* Patients will be recruited only if cancer-free at clinical evaluation time.
* For the cases a confirmed TC diagnosis who received one or more cycles of CBCT-based chemotherapies (CBCT group, Arm 2)
* For the cases with a confirmed TC diagnosis who received one or more cycles of CBCT-based chemotherapies and underwent BMT for relapsed refractory disease (CBCT \& BMT group, Arm 3).
* For the comparison cohort, biopsy-proven TC patients who had surgery for or surveillance of their testicular cancer and never received CBCTCBCT or BMT (surgical/surveillance, Arm 1)

Exclusion Criteria

* Prior known myocardial infarction (MI), atherosclerotic cardiovascular disease (ASCVD)
* Significant renal disease (GFR\<40)
* Allergy to iodinated contrast
* Antecedent chemotherapy for another primary cancer.
Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules

Among the causes of the solitary pulmonary nodule (SPN), benign causes including tuberculosis was noted on 15 to 60 percents in various studies.

Although the characteristics of chest imaging is helpful in diagnosis and percutaneous needle biopsy for pulmonary nodule has been represented high diagnostic yield in many reports, but still surgical biopsy has been needed in definite diagnosis of pulmonary nodules in many cases.

The aim of this study is to evaluate the usefulness of interferon-gamma release assay in addition to the percutaneous needle biopsy, in diagnosis of pulmonary nodules.

Among the patients who failed to diagnosis by percutaneous needle biopsy and needed to have Surgical biopsy, thirty percents of the patients were diagnosed as benign nodules and about six percents were diagnosed as tuberculosis in Seoul National University Hospital during 2007-2008.

The investigators want to know whether conducting an interferon-gamma release assay in addition to percutaneous needle biopsy is helpful in diagnosis of lung nodules.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* in patients with solitary pulmonary nodule
* who had percutaneous needle biopsy for diagnosis of lung nodule

Exclusion Criteria:

* patients who do not agree the study enrollment
Evaluation of Preoperative Investigations in Patients With Liver Cancer

The aim of the study is to evaluate the diagnostic procedures emission tomography in combination with a CT scan (PET/CT) and endoscopic ultrasonography (EUS) in the preoperative evaluation of resectability of patients with primary or secondary liver cancers.


Eligibility Criteria:
Inclusion Criteria:

* all patients who are referred to The Department of Surgery, Odense University Hospital, for surgical treatment of suspected or biopsy proven primary or secondary liver cancer.

Exclusion Criteria:

* age less than 18 years
* patients who are not fit for liver surgery because of co-morbidity
* patients for whom the extra investigations in the study are considered to give an increased risk because of co-morbidity such as

  * Patients with s-creatinin \> 150 micromol/l
  * Patients who take peroral antidiabetic drugs or have a poorly regulated diabetes mellitus
* patients who do not understand the patient information
* patients who do not want to participate