cyrilzakka/clinical-trials huggingface dataset:
Radiation Therapy and Tamoxifen in Treating Children With Newly Diagnosed Brain Stem Glioma

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Tamoxifen may kill tumor cells by blocking the enzymes necessary for cell growth. Combining radiation therapy with tamoxifen may be effective in treating newly diagnosed brain stem glioma.

PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy and tamoxifen in treating children who have newly diagnosed brain stem glioma.

OBJECTIVES:

* Determine whether high-dose tamoxifen with radiotherapy increases the median survival and overall survival of children with newly diagnosed brain stem gliomas.
* Determine the time to neurologic or radiographic progression in patients treated with this regimen.
* Determine the acute and chronic toxicity of high-dose tamoxifen in these patients.

OUTLINE: This is a multicenter study.

Patients undergo radiotherapy once daily 5 days a week for 6 weeks. Within 2 weeks after the initiation of radiotherapy, patients receive oral high-dose tamoxifen once daily. Tamoxifen continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study within 4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Newly diagnosed tumor of the brain stem (diffuse intrinsic lesion centered on the pons)

  * Radiological and clinical diagnostic criteria allowed (biopsy not required)
  * The following astrocytic tumors are allowed if histologically confirmed:

    * Diffuse astrocytoma (all subtypes)
    * Anaplastic astrocytoma
    * Glioblastoma
    * Pilocytic astrocytoma (grade I)
* Less than 6 months since diagnosis
* At least 1 of the following signs of brain stem tumor:

  * Cranial nerve deficit
  * Long tract signs
  * Ataxia
* No focal lesions of the brain stem (either clearly marginated or cystic), cervicomedullary tumors, tumors predominately exophytic, or pontine tumors diagnosed as pilocytic on biopsy

PATIENT CHARACTERISTICS:

Age:

* Under 20

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Not pregnant or nursing
* No frequent vomiting or other medical condition that would preclude oral medication intake

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy for brain stem glioma

Endocrine therapy:

* Concurrent steroids allowed

Radiotherapy:

* No prior radiotherapy for brain stem glioma

Surgery:

* Not specified

Other:

* Concurrent anticonvulsants allowed
The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Ketosis and Ketoacidosis

Background:

Ketosis after bariatric surgery is a metabolic process that occurs when the body breaks down fat for energy because of not getting enough carbohydrates.

Insufficient production of ketone bodies reduces the rate of weight loss, and excessive amounts of ketones can lead to ketoacidosis or liver failure in patients with nonalcoholic steatohepatitis (NASH).

The investigators hypothesize that weight loss is directly related to calorie intake, and a significant reduction in carbohydrate content leads to increased ketosis and the risk of ketoacidosis.

Objectives:

The study aimed to compare the incidence of ketoacidosis and liver failure in patients with NASH with different intakes of carbohydrates in the early postoperative period after gastric bypass. In addition, the investigators want to find out how carbohydrate restriction will affect weight loss for up to 1 year.

Methods:

This study is a three-arm randomized controlled trial. All patients will undergo laparoscopic one anastomotic gastric bypass. In the postoperative period, all patients will receive normal daily amounts of protein and fat. Depending on the amount of carbohydrates that will be received after surgery, patients will randomly (no mask) be divided into three groups:

The first group: 51-75% deficit in carbohydrates Second group: 26-50% deficit in carbohydrates The third group: has a 1-25% deficit in carbohydrates.

Primary outcome measurement Compare the incidence of ketoacidosis and liver failure in three groups of patients with NASH with different intakes of carbohydrates in the early postoperative period after gastric bypass.

Secondary outcome measurements Change in body mass index (Δ BMI). Effect weight loss for up to 1 year.

Eligibility Criteria:
Inclusion Criteria:

* obesity patients BMI 30-50 kg/m2.
* patients with nonalcoholic steatohepatitis (NASH).

Exclusion Criteria:

* patients with active physical sports
* diabetes
* cirrhosis
Detection of Autologous DEHP (DiEthylHexyl Phthalate)-Free Blood Transfusion in Anti-doping

The aim of the proposed project is to perform a clinical study in which volunteers will receive autologous blood transfusions in DEHP-free blood bags.


Eligibility Criteria:
Inclusion Criteria:

* Have to fill the swiss blood donation formulary

Exclusion Criteria:

* Anemia
* Cardiovascular disease
* Neurologic disease
* Not performed a blood donation for 5 weeks ago the start of the study.
* Immunological disease
Electrical Stimulation to Accelerate Wound Healing

A clinical study at the Baylor College of Medicine, Division of Vascular Surgery and Endovascular Therapy, is being proposed to test the efficacy of a novel electrical stimulation platform named the Tennant Biomodulator designed by AVAZZIA to accelerate wound healing, relieve pain and improve mobility in patients with diabetic foot ulcers.

Electrical stimulation may offer a unique treatment option to heal complicated and recalcitrant wounds, improve flap and graft survival, and even reduce the likelihood of ulceration. Electrical stimulation has been suggested to reduce infection, improve cellular immunity, increase perfusion, relieve pain, improve plantar sensation, and accelerate wound healing.

Electrical stimulation could have positive effect on not only increasing skin perfusion in patients with diabetes but also could improve mobility and balance via enhancing plantar sensation as demonstrated in our recent study. Thus, plantar stimulation not only may be beneficial to accelerate wound healing in diabetic foot ulcer (DFU) patients but also may assist to improve mobility and reduce the likelihood of recurrence of ulcers.

This study is proposed to examine the effectiveness of an innovative portable electrical stimulation platform (Tennant Biomodulator by AVAZZIA) to accelerate wound healing in DFU patients. It is hypothesized that 1) electrical stimulation will have an immediate effect on increasing skin perfusion (immediate benefit) and 2) daily use of the Tennant Biomodulator for 4 consecutive weeks is effective to speed up wound healing, increase skin perfusion, reduce pain, and improve balance and mobility in DFU patients (long term benefit)

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* 18-85 years old
* Clinically confirmed diabetes (ADA criteria)
* Clinically confirmed Peripheral Neuropathy
* One or more active non-infected ulcers
* Subject or responsible caregiver is willing and to maintain the required offloading (as applicable the location of the ulcer) and applicable dressing changes and electrical stimulation application.

Exclusion Criteria:

* Subject has a demand-type cardiac pacemaker, implanted defibrillator or other implanted electronic device
* Is pregnant
* Is nursing or actively lactating
* Has Renal Disease
* Active wound infection
* Active Charcot foot
* Non-ambulatory (unable to walk 40 feet with or without assistive device)
* Bilateral AK/BK amputation
* Active drug/alcohol abuse
* Dementia or impaired cognitive function
* Excessive lymphedema
* Osteomyelitis and/or gangrene
* Unable to comply with research appointments (e.g. long travel) Wide spread malignancy or systemically imumno-compromising disease
* Subject has a history of or any intercurrent illnesses or conditions that would compromise the safety of the subject according to judgement of a qualified wound specialist.
Accuracy of the Association Between the "PA-R" and "ACT" Questionnaires in Asthmatic Pediatric Patients

A patient with asthma requires daily and long-term pharmacological treatment when symptoms are frequent and/or severe. International guidelines suggest increasing or reducing pharmacological therapy based on the individual's needs. On average, follow-up visits for a child with asthma treated with maintenance pharmacological therapy should be every 3 months. This period is often challenging to meet in clinical practice because of long waiting lists. An alternative solution could involve the use of structured questionnaires that the patient should fill out on their own (if aged 12 or older) or with the help of parents (if younger than 12). A similar solution is also suggested by international asthma guidelines. The doctor, upon receiving the questionnaire, for example through email, could make the appropriate management decisions and communicate them to the patient, again through email. For remote use, the test should have optimal sensitivity and specificity, otherwise, there is a risk of either underestimating or overestimating the need for adjustments to the maintenance therapy. The most commonly used is the Asthma Control Test (ACT), which did non demonstrate an elevated sensibility and specificity as revealed by different studies. Tripoli et al., for example, reported that 22% of children aged 12 or older with an ACT score = 25 have asthma and a fall in FEV1 \>12% after physical exertion. Considering the information above, we considered combining the ACT with the Physical Activity-Rating (PA-R), a validated questionnaire for measuring the level of physical activity. It is possible that one of the issues lies in the lack of quantification of the patient's physical activity level when administering the ACT. Through an interventional study, our intention is to assess the diagnostic accuracy of the ACT + PA-R combination (test under experimentation) compared to ACT (traditional test) and compared to reference standard (spirometry before and after exertion). The goal of the study is to evaluate whether the combination of a high score in both the PA-R (\>7) and ACT (\>21) can accurately identify patients with well-controlled asthma, i.e., those with normal spirometry after physical exertion.


Eligibility Criteria:
Inclusion Criteria:

* Correctly diagnosed asthma;
* Age between 6 and 15 years;
* Understanding and signing of the informed consent by the parent/guardian;
* Understanding and signing of the assent by the minor.

Exclusion Criteria:

* Inability to correctly perform spirometry;
* Inability to correctly perform the exercise test;
* Unwillingness to sign the informed consent by the parent/guardian;
* Unwillingness to sign the assent by the minor.
EnSite Precision™ 2.0 Registry

The objective of this registry is to assess and characterize the use and performance of the EnSite Precision™ Cardiac Mapping System and the EnSite Precision™ Software V2.0 in a variety of electrophysiological (EP) procedures and clinical settings. This registry will assess the clinical performance of the system in a controlled, real-world environment after commercial release.

Up to 500 subjects will be enrolled in up to 50 sites worldwide.

Data will be collected at enrollment/baseline, procedure and pre-discharge. There is no long-term follow-up required for this registry.

The anticipated registry enrollment is about 6-7 months.

The use of the EnSite Precision™ Cardiac Mapping System will be assessed by collecting feedback from physicians/operators through specific questions.

The performance of the EnSite Precision™ Cardiac Mapping System will be assessed by collecting procedure data and adverse events.

A detailed Data Management Plan will be established to ensure consistency of the data. This document will include procedures used for data review, database cleaning, and issuing and resolving data queries. If appropriate, the Data Management Plan may be updated throughout the registry duration. All revisions will be tracked and document controlled.

Case Report Form data will be captured in a validated electronic database management system hosted by St. Jude Medical.

Centralized monitoring will occur through routine internal data review. This monitoring is designed to identify missing and inconsistent data, data outliers, and potential protocol deviations that may be indicative of site non-compliance. On-site monitoring may occur at the discretion of the sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Patients indicated for a cardiac EP study and ablation procedure using a 3D mapping system
* Over 18 years of age
* Ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations

Exclusion Criteria:

* Contraindication to anticoagulation
* Presence of thrombus
* Implanted with mechanical prosthetic heart valve
* Recent (\<3 months) myocardial Infarction or unstable angina or coronary artery by-pass
* Pregnant or nursing
* Individuals whose willingness to volunteer in a registry, in the judgment of investigator or public authorities, could be unduly influenced by lack of or loss of the autonomy due to immaturity, or mental disability, or adverse personal circumstances, or hierarchical influence
Investigation of Low-intensity Focused Ultrasound Parameters

This project examines the effects of different brain stimulation settings on muscle contractions. The investigators believe this study will help to better understand noninvasive brain stimulation techniques that may have the potential to aid in addiction, pain, and mental health issues. Participants undergo structural imaging, an fMRI and CT. These images are used to align the low-intensity focused ultrasound (LIFU) and transcranial magnetic stimulation (TMS) devices to temporarily change brain activity. Electromyography (EMG) will be used to record muscle contractions on the hand.


Eligibility Criteria:
Inclusion Criteria:

* Above criteria and must understand and speak English.

Exclusion Criteria:

* Contraindications to MRI, CT, or TMS

  1. Claustrophobia
  2. Pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
  3. Pregnancy
  4. Active medical disorder or treatment with potential CNS effects
  5. History of neurologic disorder
  6. History of head injury resulting in loss of consciousness for \>10 minutes
  7. History of alcohol or drug dependence
  8. Failure to provide a social security number or tax ID number. This is required for tax purposes or payment cannot be processed.
Recruitment Maneuvers in ARDS: Effects on Respiratory Function and Inflammatory Markers.

Acute Respiratory Distress Syndrom is associated to lung and systemic inflammation, which could be worsened by mechanical ventilation.This included a proteasis - antiproteasis imbalance which could participate to a fibrosis process.

Low tidal-volume ventilation (6 mL/kg) with low plateau pressure (\< 30 cm H2O) has been proved to decrease mortality when compared with more conventionnal high-volume (12 mL/kg) ventilation.Moreover, this lung-protective approach decrease lung annd systemic inflammation.

Using recruitment maneuvers (i.e. the application during a short time of high pressures with the intention to re-open the lung, followed by an increase of PEEP-level to keep the lung open, in an attempt to decrease the alveolar shear-stress) has been proposed to improve oxygen and to reduce bio-trauma.

However, the effect of such maneuvers on the inflammatory response and on the evolution of ARDS remains unknown.

Therefore we have planned a randomized, monocentric, controlled trial consisting of the comparison of two approaches of mechanical ventilation in Acute Lung Injury. This trial will include 30 hemodynamically stable patients fulfilling the ALI or ARDS criteria defined by the US and European Consensus Conference.

They will be randomized in two groups: standard low-volume ventilation vs. recruitment maneuvers.

The main objective of our study is to compare both ventilatory strategies in termes of lung and systemic inflammation.

The primary outcome measures will be the proteasis activity as measured in broncho alveolar fluid (BAL) and pro- and antiinflammatory cytokines activity as measured in the BAL and in the blood. Two samples (BAL and blood) will be obtained at a 48-72 hours interval. In the recruitment maneuver group, the first BAL will be obtained two hours before the maneuver.

Secondary outcome measures will be gaz exchange, respiratory mechanics, systemic hemodynamics and visceral dysfunction scores.


Eligibility Criteria:
Inclusion Criteria:

* age over 18
* hospitalization in the ICU
* under mechanical ventilation
* Acute Lung Injury (ALI)criteria
* first week of ALI
* hemodynamic stability (mAP \> 75 mmHg since one hour)
* informed consent signed (patient or relatives)

Exclusion Criteria:

* pregnancy
* obesity (BMI \> 40 kg/M2)
* high probability of D-28 death
* severe burn injury
* severe hepatic cirrhosis (Child-Pugh C)
* aplasia
* HIV or CHV infection
* use of more than 0.5 mg/kg of steroïds
* immunosuppressor agents
* hemopathy
* contra indications for BAL
* contra indications for recruitment maneuvers
* baro-traumatism
* left cardiac failure
* chronic respiratory failure
* inclusion in another study during the past month
Evidence-Based Medicine Electronic Decision Support Study

The purpose of this study is to analyze the effect of the Evidence-Based Medicine electronic Decision Support (EBMeDS) automatic reminders in primary health care.

Hypothesis (1)is that in the intervention group the total number of EBMeDS reminders will decrease compared to the control group.

Hypothesis (2) is that in the intervention group the quality measures will increase faster compared to the control group at follow-up time.


Eligibility Criteria:
Inclusion Criteria:

* All residents of Sipoo who have patient ID number in the Mediatri electronic patient record system in Sipoo Health Centre

Exclusion Criteria:

* Those residents who's occupational health care is produced by Sipoo Health Centre
Palliative Care in Patients With COVID-19: Analysis of Costs of Hospitalization in Wards and Intensive Care Units

The confrontation of COVID-19 foreshadowed a serious crisis of scarce health resources worldwide. To assist in this confrontation, the Palliative Care Scientific Technical Core of the Clinical Hospital, School of Medicine, Sao Paulo University (USP) elaborated a Triage Protocol for Palliative Care (PALI-COVID Tool) and it was possible to categorize the patients in three groups, according to the risk of death and needs of Palliative Care (PC), through the clinical evaluation of the patient that also directed them to the hospitalization resource according to their need (ward x ICU).

The patients grouped as with higher risk of death and PC needs (green group) by PALI-COVID Tool were those with a profile of end-of-life, signs of clinical deterioration and risk of death on admission and thus indicated for admission to the COVID-19 Palliative Care Inpatient Unit, however some were admitted to the ICU. Objective: to analyze the direct costs of hospitalization of COVID-19 Palliative Care patients in Palliative Care Inpatient Unit and ICU screened as green group by the COVID-19 Screening Protocol developed in the institution. Methods: observational, cross-sectional and retrospective study of the service database of patients over 18 years of age screened as the green group (PALI-COVID). The variables to be investigated are related to sociodemographic and clinical data, length of stay and hospitalization scenarios, time to call for PC, outcome and costs.

Eligibility Criteria:
Inclusion Criteria:

* inpatients with severe forms of COVID-19 between April 08 and July 31, 2020
* positive reverse-transcriptase polymerase chain reaction (RT-PCR).
* patients with terminal illness and high clinical risk of death before COVID-19.
* those admitted to an ICU or palliative care unit.

Exclusion Criteria:

* absence of hospitalization cost data in the institution's electronic records
FIT and Fecal Calprotectin in Patients With Chronic Lower GI Symptoms

Chronic lower gastrointestinal (GI) symptoms, including lower abdominal pain, bowel habit change, bleeding per rectum, and abdominal bloating, are caused by functional gastrointestinal disorders (FGID) and organic intestinal disorders, including colorectal cancer and chronic colitis. The presence of alarming features, such as the age of onset older than 50 years, rectal bleeding, anemia, significant weight loss, and family history of colorectal cancer, indicates organic diseases, and colonoscopy should be required. However, using only alarming features may not be sufficiently accurate. For example, anemia or significant weight loss, which are highly specific for organic disorders, usually occur in late-stage diseases. Conversely, the parameters with high sensitivity, such as the age of onset after 50 years, have a low specificity; colonoscopy in these patients may not be urgent. Therefore, tests that can help discriminate organic from functional diseases are warranted. Immunochemical fecal occult blood tests (iFOBT) and fecal calprotectin (FC) are biomarkers that indicate organic lesions in the gastrointestinal tract and could help diagnose patients with lower GI symptoms more accurately.

This study was a single-center, prospective cohort study undertaken at Siriraj hospital between March 2020 to November 2022. Eligible participants were required to collect their stool samples one to two days before the bowel preparation. The stool was sent for fresh smear examination, quantitative FIT (OC-SENSOR, EIKEN CHEMICAL, Japan), and quantitative fecal calprotectin (EliA Calprotectin 2, Phadia, Sweden). Blood samples were obtained on the day of the colonoscopy and were tested for complete blood count, albumin, and C-reactive protein (CRP) levels. In addition, clinical information was obtained, including alarm features such as the age of onset older than 50 years, rectal bleeding, anemia, significant weight loss, and family history of colorectal cancer. Colonoscopic findings and histopathological findings were used as the reference standard for diagnosis. We analyzed the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for diagnosing significant ileocolonic lesions, including colorectal cancer, advanced adenoma, and colitis, of each diagnostic modality comparing to the reference standard.

Eligibility Criteria:
Inclusion criteria

* age of at least 18 years
* patients with at least one month of any lower gastrointestinal symptoms are as followings; lower abdominal pain, constipation, diarrhea, rectal bleeding, change in stool caliber, abdominal bloating,
* patients who are scheduled for a colonoscopy

Exclusion criteria

* incomplete colonoscopy
* incomplete stool collection
Institut Paoli Calmettes Cervical Cancer Database

Database of Institut Paoli-Calmettes patients diagnosed with cervical cancer


Eligibility Criteria:
Inclusion Criteria:

* Patient with a diagnosis of cervical cancer

Exclusion Criteria:

* Non applicable