cyrilzakka/clinical-trials huggingface dataset:
Salivary Biomarkers in Pediatric Traumatic Brain Injury

By studying individual biomarkers in body fluids such as saliva, there is a potential for detecting injury to the brain resulting from an acute traumatic even that may not be detectable by conventional neuroimaging like CT scans.

Although identification of biomarkers following TBI is a rather novel area of research, few studies that have been done in patients with severe TBI and biomarkers from serum and cerebrospinal fluid have shown to have prognostic significance. However there are no prior studies looking at biomarkers in salivary specimens. In this study we will include patients with moderate and severe TBI who require inpatient admission, and will study 3 specific salivary biomarkers. This is a unique project, since salivary specimen collection is easy and non-invasive and can be collected at any site even on a sports field by using a simple absorbable swab resembling a cigarette stub, unlike blood or CSF that can be highly invasive. Salivary specimens can also be frozen and stored for long periods of time prior to testing. If our study detects abnormalities in levels of these biomarkers when compared to healthy controls, and children with extra-cerebral injuries, in future studies we can look at children and adolescents with minor head traumas and concussions who are discharged from the emergency department after evaluation, and study their long-term outcomes and correlation with salivary biomarkers.

Specific aims:

To study levels of three specific biomarkers in salivary specimens (GFAP, S100B and NSE) in children with moderate TBI (GCS: 9-12) and severe TBI (GCS: \<8) admitted to a pediatric trauma referral center. These biomarkers have been shown to have prognostic significance in prior studies using serum and CSF.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 0 to 20 who present to the pediatric ED or trauma bay with an isolated acute head injury (moderate or severe) and are admitted for inpatient management;
* Pediatric patients who present to the ED with non-trauma complaints; and
* Pediatric patients who present to the ED with non-head trauma such as musculoskeletal injuries.

Exclusion Criteria:

* Patients with multisystem trauma;
* Patients with minor head trauma (GCS 13-15) discharged from the pediatric ED
* Patients with other pre-existing neurological conditions (such as cerebral palsy, chronic seizure disorder, VP shunts);
* Patients with a history suggestive of head trauma from chronic abuse;
* Incarcerated patients or patients from juvenile detention facilities;
* Refusal of parent/patient to participate for any specific reason.
Comparison of the Accuracy in Rehabilitation Exercise Between Mobile Application Actuated Rehabilitation Exercise Guidance and Routine Rehabilitation Exercise Guidance for the Primary Osteoarthritis Knee Patients

Evaluate the accuracy of physical therapy in various positions after 4 weeks of training, comparison of the accuracy in rehabilitation exercise between mobile application actuated rehabilitation exercise guidance and routine rehabilitation exercise guidance for the primary osteoarthritis knee patients


Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis of knee
* Have an android phone and use the application

Exclusion Criteria:

* There are other complications that may affect physiotherapy
* Communication problems
* Has been trained in physical therapy for osteoarthritis patients
* Have had total knee arthroplasty
Clinical Response of EXTOR (Amlodipine/Valsartan) in Newly Diagnosed Hypertensive Patients.

The American College of Cardiology/American Heart Association hypertension guidelines recommend treatment initiation with dual antihypertensive therapy in adults with stage 2 hypertension (corresponding to grade 1 and 2 in the ESH classification) and an average BP \>20/10 mm Hg above target. Amlodipine and valsartan are two of the most commonly prescribed medications for the treatment of hypertension (high blood pressure). In Pakistan multiple studies were conducted on Hypertension and use of Single Pill Combination in uncontrolled Hypertension. However, no study was conducted to assess the role of Single Pill Combination (SPC) like Amlodipine and Valsartan in newly diagnosed hypertension and to assess their quality of life by patients' satisfaction with their medication after managing the hypertension with the SPC.

To assess the effectiveness of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients in 8 weeks.

* Change from Baseline to 8 weeks in Systolic Blood Pressure (SBP) From standard Blood Pressure Measurement.
* Change from Baseline to 8 weeks in Diastolic Blood Pressure (DBP) From standard Blood Pressure Measurement.
* Change from Baseline to 8 weeks in the Health-Related Quality of Life of newly diagnosed hypertensive patients managed by Extor: assess by Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9)
* Change from baseline to 4 weeks in Diastolic Blood Pressure (SBP) From standard Blood Pressure Measurement
* Change from baseline to 4 weeks in Diastolic Blood Pressure (DBP) From standard Blood Pressure Measurement
* Change from baseline to 4 weeks in the Health-Related Quality of Life of newly diagnosed hypertensive patients managed by Extor: assess by Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9)
* To assess the overall safety of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients.

Note: The safety is assessed in all subjects who received at least one dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a clinical history of Hypertension (systolic blood pressure greater than or equal to 140 mmHg or a diastolic blood pressure greater than or equal to 90 mmHg) and never had antihypertensive treatment.
* Patient aged ≥18 and ≤70 years inclusive of either sex.
* Patient with ability to understand and sign written informed consent form.

Exclusion Criteria:

* • Patients with already on antihypertensive treatment or secondary hypertension

  * Pregnant women or nursing mothers
  * Patients with acute illnesses or psychiatric diagnosis
  * Known hypersensitivity to Extor product, the metabolites, or formulation excipients.
  * Treated with Extor to evaluate safety as per approved prescribing information for Extor in Pakistan.
A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia

Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the AG-CLI-0206-LTFU study

The study is designed to assess the long term safety of subjects who have been treated in the phase 3 study with AMG0001. A health questionnaire will be used to collect specific information from the subject every 6 months. Only those subjects that were randomized in the AG-CLI-0206 study and who received AMG0001 are eligible to participate in this long term follow-up study. Subjects that received placebo will not be eligible for participation in this study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have been treated with AMG0001 in the AG-CLI-0206 study.
* Subjects who have provided consent for this long term follow-up study either directly or through a legally authorized representative.
* Subjects who have provided a release of information to the sponsor.

Exclusion Criteria:

* Subjects who were not enrolled in the AGCLI-0206 study.
* Subjects who enrolled in AG-CLI-0206 and who were not treated with AMG0001.
* Subjects who have not provided consent to this long term follow-up study either directly or through a legally authorized representative.
* Subjects who have not provided a release of information for the Sponsor to contact them directly via phone, email and/or mail.
Cardiovascular Outcomes SGLT-2 Inhibitors Versus GLP-1 Receptor Agonists

Patients with type 2 diabetes (T2D) suffer from an excess risk of adverse cardiovascular events. Recently, two classes of glucose lowering agents, namely SGLT-2 inhibitors (SGLT2i) and GLP-1 receptor agonists (GLP-1RA), have proved superior to placebo in protecting T2D patients from cardiovascular events in dedicated trials. Patient populations in such trials were mainly composed of T2D individuals with established cardiovascular disease (CVD) or at very high risk for CVD. In addition, no clinical trial has so far compared cardiovascular outcomes of T2D associated with SGLT2i versus GLP-1RA. In addition, whether different results would incur in patients at lower CVD risk is unclear. On this basis, we designed this retrospective real-world study to compare cardiovascular outcomes of patients newly treated with SGLT2i versus GLP-1RA in routine clinical practice


Eligibility Criteria:
Inclusion Criteria:

* Italian citizens, residing in the Region
* Registered as beneficiaries for at least one year between January 1st, 2012 and September 30th, 2018
* Diagnosis of type 2 diabetes
* Newly initiating SGLT-2 inhibitors or GLP-1 receptor agonists
* Being treated with glucose lowering medications before (at least one prescription of an antidiabetic agent in ATC class A10B prior to the index date)
* Time between the index date and the last SGLT2 inhibitors or GLP-1 receptor agonists prescription shorter than 8 months,
* Follow-up time or time-to-endpoint of at least three months

Exclusion Criteria:

* Patients who started SGLT2i or GLP-1RA before 2014
* Patients with an insufficient exposure time
* Patients with an incident event within three months after the index date.
Proof of Concept Study With an Endothelin Receptor B Inhibitor (BQ-788) for Human Melanoma

Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788) or vehicle was preformed in 5 melanoma patients to have a preliminary analysis of safety, dose, duration and relevance of results observed in pre-clinical studies to the human disease.


Eligibility Criteria:
Inclusion Criteria:

* Written Informed consent
* Histologically confirmed melanoma
* Disease stage III or IV
* At least 2 injectable and surgically removable cutaneous metastasis
* Age \> 18 years
* Clinically stable medical condition

Exclusion Criteria:

* Primary ocular melanoma
* Symptomatic intracranial melanoma
* History of severe neurological, cardiovascular, renal, hepatic, endocrinological, respiratory, bone marrow, autoimmune or infectious (HIV) disease
* Pregnancy or lactation
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer

This trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.


Eligibility Criteria:
Inclusion Criteria:

* Subject was previously enrolled in a denosumab phase 3 study and participated in the Open-label Extension portion of that study.
* Subject or subject's legally acceptable representative has provided informed consent.

Exclusion Criteria:

* Subject is of child bearing potential and planning to become pregnant within 7 months after the end of treatment.
* Subject is of child bearing potential and is not willing to use, in combination with her partner, two highly effective methods of contraception during treatment and for 7 months after the end of treatment.
* Subject has known sensitivity to any of the products to be administered during dosing.
* Subject will not be available for protocol required study visits or procedures, to the best of the subject and investigator's knowledge.
* Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
Pre-emptive Kidney Transplantation Quality of Life

The main objective is to assess the psychological impact of pre-emptive kidney transplantation on patients' quality of life taking into account psychological adjustment (response shift), compared to patients who have experienced a short pre-transplant dialysis period of less than 36 months.

The following outcomes will also be compared between Patients with Pre-emptive Transplantation and Patients with Dialysis before Transplantation : a) changes in quality of life, subjective well-being, perceived anxiety and depressive disorders as well as perceived stress during follow-up taking into account psychological adjustment (response shift) ; b) The coping strategies (process of managing stressful circumstances) and post-traumatic growth (positive psychological change experienced as a result of the struggle with highly challenging life circumstances) ; c) The 2-year post transplantation graft survival and patient outcomes: evolution of the Graft Filtration Rate, the proteinuria level ; d) The Kidney Transplant Failure Score (KTFS, patent N°0959043) at one year post transplantation ; e) The post-transplantation time to return to work and patients compliance to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a pre-emptive transplantation from deceased and living donor and patients who have experienced a pre-transplant dialysis period of less than 36 months (matched inclusion on recipient gender and center).
* Only first and single kidney transplantation will be considered.

Exclusion Criteria:

* Re-transplantation or simultaneous transplantation (kidney-pancreas for instance)
* Patients under guardianship.
Comprehensive Intervention to Evaluate Outcomes AND Cost in Hospitalized Surgical Patients With Diabetes Mellitus (DM)

This study is being performed to evaluate whether a comprehensive discharge planning and close follow up for one year can improve clinical outcomes and cut costs of care for patients with poorly controlled diabetes. The study takes a high risk approach and is focused on patients admitted to hospital for elective surgery with HbA1c \>8%. Secondary goals include improving teamwork and communication for clinicians within the team and teaching nurse practitioners and physicians-in-training how to work effectively within interdisciplinary teams. Investigators anticipate that the results of this project may lead to the following benefits: 1) improved health outcomes for surgical patients with diabetes, 2) improved strategies for better communication within interdisciplinary health care teams, and 3) decreased health care costs.

All patients who are planned for elective surgery at the hospital are seen in the pre-operative center a few days before admission. The diabetes management team becomes involved in care of patients with HbA1c \>8.0% at this time. Once the patients are admitted to the hospital, the diabetes management team continues to follow them until they are ready for discharge. At the point of discharge, patients are randomized to one of two arms- the usual care group and the expanded diabetes management service (eDMS). The eDMS group is followed closely for 1 year after discharge by the investigators to make sure they receive appropriate care for their diabetes.

Aims of this study are:

1. To evaluate whether patients that receive the eDMS have lower re-hospitalization rates at 1 month compared to patients who receive the traditional (current) DMS. Investigators hypothesize that the eDMS program will have lower re-hospitalization rates at 1 month.
2. To evaluate whether patients that receive the eDMS have lower HbA1c levels at 1 year compared with patients who receive the traditional DMS. Investigators hypothesize that patients in the eDMS program will have lower HbA1c levels and improved diabetes-related health outcomes after 1 year in the program.

Eligibility Criteria:
Inclusion Criteria:

* elective surgery
* HbA1c \>=8% within 3 months before surgery
* Age \> 18 years

Exclusion Criteria:

* undergoing same day surgery without post-operative admission
* HbA1c \< 8%
* individuals undergoing bariatric surgery
* individuals with metastatic cancer or short life expectancy
Validation of the Thai Version CPOT and BPS in Postoperative ICU Patients

The prospective study set forth to test Thai version CPOT and BPS for validity, reliability, and practicality. After translation, both pain scales were tested for concurrent validity, discriminant validity, criterion validity, and inter-rater reliability in patients who were intubated during the postoperative period. Opinions regarding practicality were elicited via questionnaires from nurses who had been using and were familiar with these two pain scales.

The prospective study set forth to test Thai version CPOT and BPS for validity, reliability, and practicality. After translation, both pain scales were tested for concurrent validity, discriminant validity, criterion validity, and inter-rater reliability in patients who were intubated during the postoperative period. Opinions regarding practicality were elicited via questionnaires from nurses who had been using and were familiar with these two pain scales.

Eligibility Criteria:
Inclusion Criteria:

* aged ≥18 years
* be able to communicate in Thai
* intubated during postoperative period.

Exclusion Criteria:

* quadriplegia
* patients with limb or facial injuries
* patients receiving neuromuscular blockers
* patients with limb mobility adversely affected by stroke
* patients with epidural catheter used for postoperative pain control
BRCA Mutations in Latinas

Background:

- BRCA1 and BRCA2 gene mutations have been linked to a higher risk of developing breast cancer and other cancers, and may be associated with types of breast cancer that are more difficult to treat and more likely to recur. New cancer treatments are being developed specifically to treat individuals who have these gene mutations. However, more information is needed about the prevalence of these mutations in minority populations, including Hispanic/Latino populations. To study these populations, researchers are interested in collecting genetic material (DNA) and medical history information from Hispanic/Latino women who have been diagnosed with breast cancer.

Objectives:

- To collect saliva samples and medical and family history information from Hispanic/Latino women with breast cancer.

Eligibility:

- Hispanic/Latino women at least 18 years of age who have been diagnosed with breast cancer.

Design:

* Participants will complete a questionnaire with information about place of birth, languages spoken by parents and grandparents, and information about their breast cancer diagnosis.
* Participants will provide a saliva sample (2 to 3 tablespoons) for analysis.
* No treatment will be provided as part of this protocol.

BACKGROUND:

* Mutations in the BRCA1 and BRCA2 genes predispose to breast and ovarian cancer, and are increasingly recognized in prostate and pancreatic cancers.
* Basal/ Triple negative breast cancer is associated with BRCA mutations in some ethnicities.However the link between BRCA gene mutations and Basil/ triple negative disease in Hispanic/ Latino women is not known.
* Common recurrent mutations in BRCA1 and BRCA2 exist in Hispanic/ Latino communities.
* New therapies such as PARP inhibitors may be particularly effective in BRCA mutation carriers.
* Therefore a unique opportunity exists to identify women in this underserved minority that may be eligible for and benefit from new targeted therapies.

OBJECTIVES:

- The primary objective is to collect saliva samples and histology data from up to 2000 Hispanic/ Latino subjects with breast cancer as a source of DNA, and to analyze the BRCA1 and BRCA2 genes..

ELIGIBILITY:

- All Hispanics females, over the age of 18, with breast cancer will be eligible.

DESIGN:

- Natural history study of 2000 Hispanic/Latino women with breast cancer, 1000 with triple

negative disease, 1000 without.

* Obtain clinical pathology reports and relevant history data on all subjects.
* Analyze recurrent BRCA1 and BRCA2 mutations

Eligibility Criteria:
* INCLUSION CRITERIA:
* Patient must be self-identified of Hispanic/Latino origin.
* Patients must have histologically or cytologically confirmed diagnosis of breast cancer.
* Age greater than or equal to 18 years.
* Ability to understand and the willingness to sign a written informed consent document.
* Must be willing and able to provide a saliva sample, answer questionnaire data online or complete a paper questionnaire, and request a copy of their pathology report.

EXCLUSION CRITERIA:

- Males and subjects under the age of 18.
Evaluation of Three Continuation Therapies After ECT Concerning Efficacy and Cognition in Severly Depressed Patients

The purpose of this study is to evaluate three different continuation treatments after acute ECT concerning efficacy and impact on cognition in severly depressed patients.

BACKGROUND While electroconvulsive therapy (ECT) in major depression is effective, high relapse rates and cognitive effects limit its long-term use. Continuation treatment after ECT with combinations of C-ECT or psychotherapy and medication may decrease relapse rates and cognitive side effects while changing cognitive psychological variables like dysfunctional attitudes in the long-term.

CENTRAL RESEARCH QUESTIONS

* Evaluation of the efficacy of three continuation treatments aimed at preventing relapses after acute ECT
* Examination of the cognitive side effects and the changes of cognitive psychological variables during acute and continuation treatment

METHODS In a prospective, randomized, controlled, long-term study we assign 60 depressed ECT responder either to antidepressant treatment alone, or C-ECT plus medication, or cognitive behavioral group therapy plus medication. Depressive symptoms and cognition were assessed before, during, immediately after acute ECT and two, four, six, and 12 months during continuation therapy.

HYPOTHESES It is hypothesized that the use of combination continuation therapies after effective ECT leads to lower HAMD scores and lower relapse rates than the standard treatment with antidepressants alone after 6 months. In addition, we assume that the CBT group will establish more functional macro-patterns than the somatic treatments in the long term and will have the lowest HAMD scores and relapse rates after 1 year. With regard to the cognitive side effects, the autobiographical memory is expected to be the only specific part of memory being affected negatively by ECT in the short and long term.

Eligibility Criteria:
Inclusion Criteria:

* Major depressive episode (unipolar)
* Response to acute ECT (at least 50% reduction in HAMD)
* Capacity to consent
* Sufficient comprehension of the German language

Exclusion Criteria:

* Schizophrenia, schizoaffective disorder, or other psychosis
* Amnestic disorder, dementia, or delirium
* Pregnancy
* Epilepsy
* Current alcohol or substance abuse or dependence
* CNS disease or brain injury not associated with psychotropic drug exposure
* ECT in the past 3 months
* Acute suicidality
* Judiciary hospitalization
An Alternative Approach to Improve Hyperglycemia Among Type 2 Diabetes Patients

The study compared the effect of bitter melon intake and moderate exercise on postprandial glucose levels as measured by incremental area under the curve (iAUC) in eight patients with type 2 diabetes.

Background: This study compared the effects of bitter melon intake and moderate-intensity physical activity on postprandial glucose responses in type 2 diabetic patients.

Methods: A total of 8 patients with type 2 diabetes were randomly assigned to two sequences (AB, BA) with two treatments (A or B) using a 2 x 2 randomized cross-over design: A) 100 ml of bitter melon juice administered 15 minutes prior to the 75-g oral glucose load; B) 30 minutes walking at moderate-intensity performed 15 minutes after the oral glucose load.

Eligibility Criteria:
Inclusion Criteria:

* An age of 20 to 79 years
* Physician-diagnosed type 2 diabetes
* Medical clearance for physical activity from their healthcare provider

Exclusion Criteria:

* Pregnant or were receiving insulin treatment
* An allergy to bitter melon
* Medical conditions that impacted the normal the functioning of the gastrointestinal tract
* Contraindications to physical activity