cyrilzakka/clinical-trials huggingface dataset:
Identification of Biomarkers in Ischemic Stroke - Clinical Trial

The objective of the study is to determine RNA blood biomarker based on 9 genes already identified in experimental studies, whose expression would be significantly increased in patient with ischemic stroke compared to controls.

This is a monocentric study. It's a case-control study with case being first-ever ischemic stroke and controls being healthy (stroke free) subject patients paired for age, sex and cardiovascular risk or hemorrhagic stroke paired for age and sex.

Patients are followed for one year. Blood samples will be taken at inclusion, 12h, 24h, 48h, 7d, 3m and 1y. Microvesicles samples will be taken at inclusion, 7d and 3M.

Eligibility Criteria:
Inclusion Criteria:

* For ischemic stroke :
* Age \> 18-year-old
* Ischemic stroke diagnosed on clinical presentation and cerebral imaging (CT or MRI imaging)
* Inclusion inferior to 6 hours from stroke onset
* Initial NIHSS score \> 0 at the time of clinical examination
* Patients with multimodal imaging either through MRI or CT perfusion and supra-aortic vessels and intra-cerebral vessels (Willis circle) imaging \<0
* Procedure of signed consent in situation of emergency : consent of the patient if he has the possibility to sign or his representative if he is present
* For hemorragic stroke :
* Age \> 18 year-old
* Hemorrhagic stroke diagnosed on clinical presentation and cerebral imaging (CT or MRI imaging)
* Inclusion inferior to 6 hours from stroke onset
* Initial NIHSS score \> 0 at the time of clinical examination
* Hemorrhagic patients are paired for age and sex with ischemic patients
* Procedure of signed consent in situation of emergency : consent of the patient if he has the possibility to sign or his representative if he is present

For healthy controls :

* Age \> 18 year-old
* Stroke-free standardized questionnaire
* Initial NIHSS score = 0
* Rankin score = 0
* High risk cardiovascular subjects
* Controls are paired for age, sex and cardiovascular risk measured by a score (European Heart Score) with ischemic patients

Exclusion Criteria:

* Not affiliated to social security
* Patient under legal protection or deprived of liberty by a judicial or administrative decision
* Patient whose follow-up will be impossible
* Prior stroke

GROUP FOR ISCHEMIC STROKE :

- Patients with TIA and a negative cerebral CT or MRI

GROUP FOR HEMORRAGIC STROKE :

* Cerebral hemorrhage related to subarachnoid hemorrhage
* Post-traumatic hemorrhage
* Hemorrhagic transformation in patients with ischemic stroke

GROUP FOR HEALTHY CONTROLS :

- Contraindication MRI
A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation

The primary purpose is to demonstrate the bioequivalence of naproxen administered as VIMOVO manufactured at a new facility in Sweden (AstraZeneca) to that of naproxen administered as VIMOVO manufactured in the USA (Patheon) and to a marketed enteric-coated naproxen formulation.

A Phase I, Open-label, Randomised, 3-way Crossover Study to demonstrate Bioequivalence of a Single Oral Dose of Naproxen administered as VIMOVO manufactured at AstraZeneca AB compared to that of VIMOVO manufactured by Patheon Pharmaceuticals and a marketed enteric-coated Naproxen Formulation (Manufactured by Roche) in Healthy Volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female volunteer, aged 18 - 55 years (inclusive)
* Female volunteers must be non-pregnant and non-lactating and have a negative urine pregnancy test result prior to enrolment into the study.
* Female volunteers of childbearing potential must be using appropriate birth control during the entire duration of the study
* Body mass index of = 19 to =30 kg/m2 (inclusive) and weights of = 50 to = 100 kg (inclusive)

Exclusion Criteria:

* Volunteer who is likely to have unrecognized cardiovascular or cerebrovascular disease, based on history or risk factors, or who has a clinical significant ECG finding at screening
* Uncontrolled hypertension defined as resting systolic pressure \>140 mmHg or diastolic pressure \>90 mmHg at screening or admission to Period 1
* Presence or prior history of abnormal bleeding or bleeding disorders, or any volunteer with significant history of peptic ulcer disease or other acid related gastrointestinal symptoms
* Any gastrointestinal disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption
Potential Improvements in Emergency Department Care for Cancer Patients According to Clinical Staff

The goal of this Single center prospective cross-sectional study is to identify the facilitators and barriers among caregivers in the emergency department that influence disposition of patients with solid and hematology malignancies. The main question it aims to answer is to categorize the facilitators and barriers identified by three groups of emergency department (ED) staff. Participants will be asked for permission, afterwards a short interview will be held with the different ED caregivers (ED nurse, attending physician and supervising physician).

The goal of this to identify the facilitators and barriers among caregivers in the emergency department (ED) that influence disposition of patients with solid and hematology malignancies. Participants will be asked for permission, afterwards a short interview will be held with the different caregivers (ED nurse, attending physician and supervising physician) in the ED. The interviews will be held in the order of the ED care pathway, meaning ED nurse first, treating physician second and supervising physician at last. The interviews will be conducted for every patient with each of the caregivers. Each interview will be conducted after the caregiver has made the first examination of the patient. The interview focuses on several parts of the emergency care process: The first part is regarding the actions that are executed during an ED visit. We will establish which actions are executed and why. The second part is regarding the suspected outcome for the patient. The third part will be about any potential improvements to the emergency care process for the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients with solid or hematological malignancies and receiving system therapy or having received systemic therapy within the last 3 months.
* Presented at or admitted from the emergency department for the oncology, hematology, neuro- or lung-oncology clinical unit.
* Awake and conscious.
* Possible to answer questions within the same shift / day after presentation in the ED.

Exclusion Criteria:

* \<18 years old.
* Only received a surgical intervention as cancer treatment.
* Not willing or able to give written informed consent.
Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Stroke Patients

A Feasibility Study to evaluate the initial safety and performance of the RapidPulseTM Aspiration System in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO).

The purpose of this study is to evaluate the initial safety and performance of the RapidPulse Inc. RapidPulseTM Aspiration System as frontline approach for use in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO). This is a prospective, multi-center, open label study comparing the safety and performance of the RapidPulseTM Aspiration System with non-randomized retrospective controls who otherwise meet the same study inclusion/exclusion criteria. The study will enroll a maximum of 100 participants in the Treatment Arm and a maximum of 200 participants in the Control Arm at in up to 10 centers in Europe and/or Latin America. Subjects data will be collected through hospitalization with a 3 months post-procedure study visit.

Eligibility Criteria:
Key Inclusion Criteria:

* Age 18 years or older
* Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6 with symptom onset (or last seen normal) up to 24 hours
* Large vessel occlusion in the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 segments, basilar or vertebral artery

Key Exclusion Criteria:

* Evidence of hemorrhage
* Significant mass effect and/or midline shift
* Vessel tortuosity too difficult to allow endovascular access per investigator judgment
* Severe or fatal co-morbidities
A Brief Parental Intervention on Learning and Education in Childhood Cancer

The purpose of this study is to assess whether a brief intervention about learning and education is both practical and acceptable for parents of children with cancer.

After being provided details about the study, participants signing the study consent form complete pre-intervention questionnaires. Participants then complete a brief psychoeducational intervention, via a HIPAA-compliant web and video conferencing platform on Zoom. The intervention is followed by completion of a post-intervention evaluation form. The consent form and study questionnaires are completed through Research Electronic Data Capture (REDCap), a secure web-based application.

Eligibility Criteria:
Inclusion Criteria:

* parent(s) or legal guardian(s) of children with cancer
* preferred language for oral and written communication is English
* 18 years of age or older
* 1 or 2 parents or legal guardians can participate for each child

The child must also meet the following for the parent(s)/legal guardian(s) to participate:

* diagnosis of cancer
* child is actively receiving cancer treatment at University of New Mexico Hospital or recently completed treatment (within 0-6 months post-treatment)
* child is between the age of 3 and 14
* child resides in New Mexico

Exclusion Criteria: Parents of children who are wards of the state are excluded (including children in custody of the NM Children, Youth \& Families Department).
Validity, Reliability of Neck Disability Index in Albanian

To translate and validate the Cervical Disability Index (NDI) into Albanian for use in the Albanian-speaking population

The cross-cultural adaptation will be carried out according to the internationally recommended methodology, following the guidelines: translation, back-translation; dissemination of questionnaires and data collection and analysis.

Psychometric properties will be assessed by administering the questionnaire to approximately 400 participants. Reliability will be estimated by assessing stability and homogeneity.

Eligibility Criteria:
Inclusion Criteria:

* Myofascial syndrome
* Headache
* muscular pain
* articular pain
* arthirtis

Exclusion Criteria:

* contraindications to manual therapy
* severe trauma
* tumor
* metabolic disease
Image-Enhanced Endoscopy (IEE) for Diagnosis of Non-Erosive Reflux Disease

When treating persistent heartburn from gastroesophageal reflux disease (GERD) that does not respond to conventional treatment (a class of medications called proton pump inhibitors), it is important to be able to distinguish between erosive GERD and non-erosive GERD (called NERD).

Currently the best method the investigators have to make this distinction is esophageal 24-hour pH and impedance testing. The test involves inserting a catheter into the esophagus through the nose and having the catheter maintained in this position for 24 hours This test is invasive, can be uncomfortable, and it is expensive and time consuming.

The investigators are hoping that image enhanced technology will identify characteristics that are found more commonly in patients with non-erosive GERD compared to controls and therefore provide evidence that may allow us to replace pH and impedance testing with the image enhanced endoscopy as the best way to diagnose NERD.

Participants will be either patients undergoing an upper endoscopy as part of their standard clinical evaluation for heartburn that does not respond to PPIs or patients undergoing standard clinical evaluation endoscopy for other reasons.

Evaluation of the utility of image-enhanced endoscopy (IEE) in the diagnosis of non-erosive reflux disease (NERD), defined as heartburn documented to be associated with reflux on impedance-pH testing in the absence of erosions on standard white-light endoscopy (WLE) during initial endoscopy.

The investigators will examine the following characteristics for IEE sensitivity, specificity, positive predictive values, and negative predictive value: squamo-columnar junction (SCJ) vascularity, micro-erosions, SCJ pit pattern, and combinations of these characteristics. The investigators will also look at abnormal morphology of intra-papillary capillary loops (IPCLS) using the newer generation Narrow Band Light (NBI-190 endoscopes and assess the identification of their presence using I-scan. Additionally, the investigators will examine real-time diagnostic yield of reflux diseases by IEE (in vivo diagnosis of reflux disease) and analyze obtained images and results to calculate inter-observer agreement.

IEE utilized will be commonly available I-scan (Pentax) and Narrow Band Imaging (Olympus).

Consecutive patients who meet eligibility criteria and are scheduled for upper endoscopy at locations specified in this record will be invited to participate.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for an upper endoscopy for anemia, weight loss, diarrhea, or screening for esophageal varices without heartburn or other GERD symptoms and patients scheduled for upper endoscopy for heartburn not resolving with PPIs

Exclusion Criteria:

* Patients who have evidence of erosive esophagitis under white-light endoscopy
* Patients with Barrett's esophagus or esophageal malignancy on prior or current endoscopy
* Patients unable or unwilling to sign informed consent
Self-management and Cognitive Function in Adults With Heart Failure

The purpose of this study is to assess the relationship between cognitive impairment, patient self-management, health, and health service use in adults with heart failure (NYHA Class 2 and 3). The research questions are:

1. How is cognitive impairment (memory, attention, global and executive function) related to various aspects of impaired self-management (knowledge of adherence, adherence to sodium restriction and medications, symptom monitoring of weight changes, and decision and action to seek care)?
2. How are these relationships altered when adjusting for medical, demographic, and psychosocial factors?
3. What are the relationships among degree of cognitive impairment, quality self-management, health status, and health service use?


Eligibility Criteria:
Inclusion Criteria:

* documented systolic heart failure
* NYHA class II, III of at least 6 months duration
* 50-85 years of age
* has a telephone (land line) or be willing to allow a telephone installed for duration of study

Exclusion Criteria:

* history of neurological disorder or injury
* moderate or severe head injury
* past or current history of severe psychiatric illness; specifically, psychotic disorders and bipolar disorder
* 5 year past or current history of alcohol or drug abuse
* history of learning disorder or developmental disability
* renal failure requiring dialysis
* history of sleep apnea
* current home telemonitoring program to assist w/ HF self-management
* cardiac surgery \< 3 months
Obesity-Related Glycine Deficiency: Investigating a Long-standing Metabolic Paradox Using Bedside and Bench Approaches

Obesity, in addition to causing abnormal glucose and lipid metabolism, is also associated with altered plasma concentrations of multiple amino acids, including increased levels of branched-chain amino acids and decreased levels of glycine. The mechanisms and consequences of obesity- related glycine deficiency are unknown.

The overall aim of this project is to comprehensively study glycine metabolic pathways in morbid obesity using stable-isotope tracer techniques in human subjects and validating kinetic findings using a cell model of oxidative stress.

This will be a single-centre, observational study. 21 individuals with morbid obesity scheduled for bariatric surgery and 21 non-obese controls will be recruit. They will undergo different study visits and procedures and the human biological materials collected will be analysed for as per aims of the studies. We believe that the glycine metabolic pathways, possibly through the optimization of gluthathione (GSH) synthesis, may provide targets to develop novel therapeutic agents.

Metabolic tracers: 1,2-\[13C2\]-Glycine, 1,2-\[13C2\]-Glycine, 2,3,3,-\[2H3\]-Serine and \[2H5\]-Phenylalanine will be infused for quantification of various pathways associated with glycine metabolism.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 21-65 years
2. BMI \< 25 kg/m2 for non-obese controls or BMI ≥ 32.5 kg/m2 for obese subjects scheduled for bariatric surgery
3. Able to provide informed consent

Exclusion Criteria:

All subjects:

1. Weight \> 150 kg
2. Renal impairment (estimated creatinine clearance estimated by Cockcroft-Gault Equation \< 60 ml/min)
3. Haemoglobin concentration \< 10 g/L
4. Serum alanine aminotransferase or aspartate aminotransferase above 2x upper limit of normal
5. Uncontrolled hypertension (BP \> 180/110 mmHg)
6. Pregnancy
7. Nursing mothers
8. Significant cardiovascular disease (e.g. acute myocardial infarction, congestive cardiac failure, ischemic heart disease, atrial fibrillation, sick sinus syndrome, supraventricular tachycardia)
9. Previous stroke
10. Uncontrolled thyroid disease
11. Surgery requiring general anaesthesia within 4-weeks before enrolment
12. Psychiatric disorders requiring medication
13. Significant alcohol intake (\> 1 unit per day for women and \> 2 units per day for men)
14. Subcutaneous insulin injections
15. Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone)
16. Cancer within the last 5-years (except squamous cell and basal cell cancer of the skin)
17. Any factors likely to limit adherence to study protocol (e.g. dementia; alcohol or substance abuse; history of unreliability in medication taking or appointment keeping; significant concerns about participation in the study from spouse, significant other or family members)

Non-obese controls 1. Known Diabetes Mellitus (diagnosed according to 2014 Ministry of Health Clinical Practice Guidelines for Diabetes Mellitus)

Obese subjects

1. HbA1C \< 9%
Lepticore in Metabolic Syndrome and Weight Loss

Metabolic syndrome is directly related to obesity. This study investigated the use of a plant based formulation to improve on the condition of people with metabolic syndrome.

LeptiCore is a proprietary combination of various ingredients which have been shown to have properties which could be beneficial to weight loss in obese and overweight human subjects. This study evaluates the effect of Lepticore on bodyweight as well as parameters associated with obesity and metabolic syndrome.

The study was an 8 week randomized, double-blind, placebo-controlled design involving 92 obese (mean BMI\>30kg/m2) participants (37 males; 55 females; ages 19-52; mean age = 30.7). The participants were randomly divided into three groups: placebo (n=30), LeptiCore formula A (low dose) (n=31) and LeptiCore formula B (high dose) (n=31). Capsules containing the placebo or active formulations were administered twice daily before meals with 300 ml of water. None of the participants followed any specific diet nor took any weight-reducing medications for the duration of the study. A total of 12 anthropomorphic and serological measurements were taken at the beginning of the study and after 2, 4, 6, and 8 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>30 kg/m2
* Total cholesterol \>200 mg/dl
* LDL cholesterol \>160 mg/dl
* HDL cholesterol \<40 mg/dl; triglycerides \>150 mg/dl
* Fasting blood glucose \>100 mg/dl
* Blood pressure \>130/85 mmHg.

Exclusion Criteria:

* Morbid obesity (BMI \>40 kg/m2 )
* Diabetes mellitus requiring daily insulin management
* Pregnancy/lactation
* Active infection
* Systemic disease such as HIV/AIDS,
* Use of any cholesterol-lowering medications 30 days prior to study
* Enrollment in another clinical study within the past 6 months.
Prenatal Yoga for Pregnancy Related Back Pain

This is a pilot feasibility study investigating prenatal yoga for pregnancy related back pain.


Eligibility Criteria:
Inclusion Criteria:

* uncomplicated pregnancies starting at 12-26 weeks of gestation
* pregnant women with and without back pain who had no regular yoga practice.

Exclusion Criteria:

* significant back pathology
* pregnancy complications
* non-English speaking
* otherwise were not able to participate (eg. transportation, scheduling issues)
Combination of Nivolumab and DHAP in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (Nivo-DHAP)

A clinical study of safety and efficacy of treatment with Nivolumab and DHAP in patients with relapsed/refractory Hodgkin's lymphoma

A Clinical Study of Safety and Efficacy of Treatment With Nivolumab and Dexamethasone, Cytarabine and Cisplatin (DHAP) in Patients With Relapsed/Refractory Hodgkin's Lymphoma

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Histologically confirmed Hodgkin's lymphoma
* Measurable disease (at least one lesion that can be accurately measured in at least two dimensions with spiral CT scan, min \> 15 mm in the longest diameter or \> 10 mm in the short axis)
* World Health Organization (WHO) performance status \< 2
* Relapsed or refractory to at least one prior treatment line
* No prior therapy with DHAP or Nivolumab
* No severe concurrent illness

Exclusion Criteria:

* History of HIV
* Active Hepatitis B or Hepatitis C infection
* Uncontrolled infection (requiring intravenous treatment) at the time of enrollment
* Pregnancy or breastfeeding
* Somatic or psychiatric disorder making the patient unable to sign informed consent
* Active or prior documented autoimmune disease requiring systemic treatment
* No receiving a live vaccine within 30 days prior to first dose of nivolumab
* History of non-infectious pneumonitis that required steroids
* Other malignancy
A Study to Evaluate the Safety and Effectiveness of Rivaroxaban (Xarelto) for Prevention of Stroke and Systemic Embolism in Indian Patients With Non-valvular Atrial Fibrillation (NVAF)

This study is planned to collect prospective data and evaluate the safety and effectiveness of rivaroxaban for the prevention of stroke and systemic embolism in Indian patients with NVAF when used in clinical practice under real-life conditions.

The study will be conducted in routine clinical practice settings. Approximately 1000 patients from India will be enrolled in this study. Patients will be observed for maximum period of 12 months after the start of Xarelto treatment or until it is no longer possible (e.g. lost to follow-up, death, withdrawal) before the end of the observation period.

The decision by the investigator to start with of Xarelto must be independent of the inclusion of a patient to the study.


Eligibility Criteria:
Inclusion Criteria:

* Patient should be an adult female or male, ≥18 years of age;
* Patient should be diagnosed with NVAF and initiated with rivaroxaban treatment for prevention of stroke or systemic embolism per investigator's routine treatment practice;
* Patient should not have received rivaroxaban in the past;
* Patient/patient's legally acceptable representative should be willing to provide written informed consent.

Exclusion Criteria:

* Patient has contraindications to receive rivaroxaban therapy according to local prescribing information;
* Patient is receiving anticoagulant therapy for indication other than NVAF and that needs to be continued as per discretion of treating physician;
* Patient is participating in an investigational program with interventions outside of routine clinical practice.