cyrilzakka/clinical-trials huggingface dataset:
Characterizing Recurrent Thromboembolism, Major Bleeding and All-Cause Death in Patients With Cancer-Associated Thromboembolism Treated With Rivaroxaban

To estimate the real-world rates of recurrent Venous thromboembolism (VTE), major bleeding and all-cause mortality in patients with Cancer-associated thrombosis (CAT) treated with rivaroxaban


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years-of-age) with active cancer
* Patient with at least one index venous thromboembolism (VTE )
* ≥6-months of continuous eligibility prior to the index VTE event (baseline period).
* Newly initiated on rivaroxaban

Exclusion Criteria:

* Patients with any medical claim for Deep vein thrombosis (DVT) or Pulmonary embolism (PE) during the 6 months pre-index date
* Patients with prescription claim for anticoagulation therapy during the 6-month pre-index VTE period
Comparison of Carotid Peak Systolic Velocity Variation With Aortic Peak Systolic Velocity Variation in Pediatric Non-Cardiac Surgery

The purpose of this study is to evaluate whether carotid Doppler peak systolic velocity can be an easy to measure possible surrogate for echocardiographic measurement of aortic peak systolic velocity variation which is an index of fluid responsiveness in mechanically ventilated children intra-operatively.


Eligibility Criteria:
Inclusion Criteria:

• Patients scheduled for mon-cardiac surgeries under general endotracheal anaesthesia in supine position with expected duration more than 1 hour

Exclusion Criteria:

* Known congenital heart disease
* Any non-sinus rhythm, arrhythmias
* Patients on vasoactive medications
* Chest wall deformities, situs non solitus (eg. dextrocardia)
* Patients scheduled for open chest surgeries
* History of neck surgery/ carotid interventions
18-FDG PET/CT Imaging and Clinical Decisions in Infective Endocarditis

The purpose of this study is to assess the impact of 18-FDG positron emission tomography (PET)/computed tomography (CT) imaging in the management of patients with suspected or proven IE in detecting cardiac valve damages and other extracardiac complications. The study will evaluate whether this procedure can change the clinical decisions (treatments, valve surgery, patients' overall care) and modify the diagnosis of IE.

Introduction:

Infective endocarditis (IE) is a rare disease, often difficult to diagnose with a high mortality rate. Extra-cardiac manifestations, which can occur in 30 to 80% of cases, impact the outcome of the disease. Identifying these manifestations may help confirm an uncertain diagnosis and optimize patients' management.

18-FDG PET/CT imaging, widely used for cancer staging, may also detect hyper-metabolic areas related to extracardiac infectious complications of IE. It provides the opportunity to detect all extracardiac IE infectious complications through a single examination. The impact of 18-FDG PET/CT imaging on the management of IE has yet to be completely evaluated.

Hypothesis:

18-FDG PET/CT implementation could result in both shortening of the initial diagnostic work-up of IE and therapeutic optimization.

Primary objective:

To evaluate the impact of 18-FDG PET/CT on patients' management, as measured by changes in IE therapeutic plans.

Secondary objectives:

* To evaluate the impact of 18-FDG PET/CT on the Duke-Li criteria for IE diagnosis
* To evaluate the performance of 18-FDG PET/CT in detecting valve damages and extracardiac complications induced by the IE
* To evaluate whether 18-FDG PET/CT may help identify the infection's portal of entry
* To evaluate whether the detection of extracardiac complications by FDG PET/CT is associated with the 6-months survival rate
* To identify clinical and biological determinants of extracardiac IE localizations and prognosis
* To determine the inter-reader interpretation of the18-FDG PET/CT results and the reproducibility in preparation and acquisition method

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged ≥ 18 years
2. Presenting IE "Duke-Li definite - Duke-Li possible" or strong suspicion of IE "Duke-Li not definite or possible, with initiation of IE antibiotic therapy".
3. Transthoracic or transesophageal ultrasound performed.
4. A stable clinical condition which does not require immediate surgery or contraindicate patient mobilization
5. Absence of cardiac surgery for the current IE episode
6. Covered by the French health insurance system
7. Having given and signed the written study informed consent to the study.

Exclusion Criteria:

1. Patient having already had a 18-FDG PET/CT in the current episode
2. Contraindication to perform a 18-FDG PET/CT
3. Early prosthetic valve IE (cardiac surgery within last 2 months)
4. Inability to understand the information form
5. Pregnant or lactating woman.
6. Cardiac surgery between inclusion and 18-FDG PET/CT
7. Participation to any clinical trial including 18-FDG PET/CT
Radiation Therapy, Temozolomide, Tamoxifen, and Carboplatin in Treating Patients With Malignant Gliomas

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Tamoxifen may make tumor cells more sensitive to radiation therapy and chemotherapy. Giving radiation therapy together with temozolomide, tamoxifen, and carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving radiation therapy together with temozolomide, tamoxifen, and carboplatin works in treating patients with malignant gliomas.

OBJECTIVES:

* Determine the progression-free and overall survival of patients with supratentorial malignant gliomas (WHO grade III or IV) receiving radiotherapy with concurrent and adjuvant temozolomide, tamoxifen citrate, and carboplatin.
* Determine the acute and delayed treatment-related toxicities in these patients.
* Determine tumor response in patients with postoperative measurable disease.

OUTLINE: This is an open-label, pilot study.

* Induction therapy: Patients receive oral temozolomide twice daily and oral tamoxifen citrate twice daily on days 1-42 and carboplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 36. Patients also receive radiotherapy on days 1-5 in weeks 1-6.
* Consolidation therapy: Beginning 4 weeks after the completion of induction therapy, patients receive temozolomide, tamoxifen citrate, and carboplatin as in induction therapy. Treatment repeats every 8 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed glioblastoma multiforme and/or anaplastic astrocytoma

  * Supratentorial tumor
  * No well-differentiated astrocytoma or glioma with oligodendroglial component
  * No multifocal glioma
* Has undergone surgery within the past 6 weeks
* No recurrent glioblastoma multiforme

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Neurological functional status 0-2
* Life expectancy \> 12 weeks
* ANC ≥ 1,200/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL
* Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
* Blood urea nitrogen ≤ 1.5 times ULN
* Total and direct bilirubin ≤ 3 times ULN
* AST and ALT ≤ 3 times ULN
* Alkaline phosphatase ≤ 3 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study completion
* No other malignancies within the past 3 years, except for carcinoma in situ of the cervix or nonmelanoma skin cancer
* No acquired immune deficiency syndrome (AIDS)
* No major medical illness or psychiatric impairment that would preclude study compliance

PRIOR CONCURRENT THERAPY:

* No prior radiotherapy to the head and neck
* No other concurrent therapy for the tumor
Orthostatic Hypotension in Elderly Nursing Home Residents

In this study the investigators aimed

1. to investigate the prevalence of orthostatic hypotension in elderly nursing home residents.
2. to investigate whether the presence of orthostatic hypotension influences the chance of successful rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* nursing home resident

Exclusion Criteria:

* patients at the palliative department
* life expectancy \< 4 weeks
* patients only temporarily admitted to the nursing home
18612 - Sun Protection Factor Assay

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing; Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA Form (Health Insurance Portability and Accountability Act).
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
A Prospective, Multi-site Clinical Study to Collect User Feedback Using Affirm® Contrast Biopsy

Currently, if a radiologist finds a suspicious lesion seen only on a diagnostic Contrast Enhanced Digital Mammography (CEDM) exam requiring biopsy the biopsy procedure would likely be performed with MRI guidance because there are currently limited solutions to biopsy with CEDM guidance. Affirm Contrast Biopsy will provide an additional solution to biopsy/localize lesions found by using a CEDM imaging modality.


Eligibility Criteria:
Inclusion Criteria:

* Females aged 40 years of age or older recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities
* Subject is able to read, understand, and sign the study specific informed consent form after the nature of the study has been fully explained to them

Exclusion Criteria:

* Subjects who require a Legally Authorized Representative (LAR) for Informed Consent
* Subjects who, based on the physician's judgement, may be at increased risk for complications associated with renal function, anticoagulant therapy, or bleeding disorders
* Subjects who have had a previous allergic reaction to IV contrast agent
Effects of ASMR on the Default Mode Network

This study investigates the effects of Autonomous Sensory Meridian Response (ASMR) stimulation on resting-state brain networks. Therefore, two resting-state fMRI scans are measured in healthy adults. Before each fMRI scan, subjects listen either to ASMR typical sounds or an audio-book (randomized cross-over-design). It is expected to find changes in the functional connectivity of the Default Mode Network caused by passive listening to ASMR.

ASMR describes a phenomenon of a perceived tingling caused by visual or auditory stimulation. This sensation can spread from the neck to the scalp and further to the back and the extremities. The triggering sound often consists of acoustic sounds (crackle, whisper, light nail-tapping) or visual images (e.g., someone is combing their hair), leading to a calm and relaxing feeling. Although ASMR is ubiquitous in platforms like "YouTube", there are just a few studies investigating the effects of ASMR. In one of those studies, Smith and colleagues examined the Default Mode Network of 11 subjects with ASMR stimulation and compared the outcome with a control group consisting of 11 subjects. They found reduced functional connectivity in the ASMR group compared to the control group. Furthermore, the connectivity between the occipital, frontal and temporal cortex was increased.

In the present study, fMRI is used to examine the effects of ASMR stimulation in a randomized cross-over design. Half of the subjects (n=14) receive the ASMR stimulation first, and then the control stimulation (audiobook). The other half of the subjects (n=14) listens to the control stimulation (audiobook) first and afterward to the ASMR stimulation. Typical "tingling" triggering sounds are presented via MRI-compatible headphones. Those sounds can consist of different noises (e.g., whisper, scratching, and knocking).

The primary outcome measure is a change in the functional connectivity of the Default Mode Network as a response to the ASMR stimulation.

Eligibility Criteria:
Inclusion Criteria:

* adults aged 18 to 99

Exclusion Criteria:

* mental disorders (dementia, depression)
* MRI contraindications
* claustrophobia
DESIGN OF A SCALE TO MEASURE COMPLIANCE WITH DRUG TREATMENT IN PATIENTS WITH ORAL CHEMOTHERAPY

Introduction: In recent years, there has been an increase in the use of oral chemotherapy, for its comfort and for allowing a higher quality of life. However, one of the main drawbacks is the lack of adherence to treatment with important clinical, social and economic consequences. In this scenario, the investigators did not have a questionnaire designed and validated to measure adherence in onco-hematological patients, a population that was erroneously considered very adherent.

The objective of the investigators is to build and validate a questionnaire to measure adherence to treatment in oncohematological patients in treatment with oral anti-cancer drugs.

Methods and analysis: An observational study to validate questionnaires will be carried out combining qualitative and quantitative research techniques. With the results of a systematic review of the literature and a qualitative study based on focus groups, a questionnaire will be designed to measure adherence in oncohematological patients in treatment with with oral anti-cancer drugs. The investigators will include patiens from two hospitals in the Valencian Community.

Discussion: It is essential to have a simple, reliable and validated instrument for measuring adherence in cancer patients undergoing treatment with oral antineoplastic agents. With this, lack of therapeutic compliance and its causes can be detected in order to establish interventions that improve it.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 in treatment with oral anti-cancer drugs (groups L01 and L02 according to the ATC drug classification), that come to the San Juan Hospital or Elda General Hospital to collect their medication, will be included.

Exclusion Criteria:

* Those patients with communication difficulties, and/or do not agree to take part in the study, will be excluded
Effect of Stellate Nerve Block in Dysphagia

This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in China. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and penetration-aspiration scale (PAS) were used to assess swallowing function.

Dysphagia is a frequent and potentially serious complication of stroke. This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in China. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and penetration-aspiration scale (PAS) were used to assess swallowing function.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.
* Dysphagia.
* Age \>18 years.
* First-time stroke.
* Steady vital signs,
* Transferred or admitted to the Department of Rehabilitation Medicine within 15d after onset.

Exclusion Criteria:

* Allergy to Lidocaine injection or vitamin B12 injection;
* Severe cognitive impairment;
* Coagulation disorders;
* Severe dysfunction of organs including heart, lungs, kidney, liver, etc.;
* Complicated with other neurological diseases;
* Dysphagia caused by other diseases or reasons.
Electrophysiological Signatures of Distinct Working Memory Subprocesses That Predict Long-term Memory Success

Healthy young adults will view pictures of items while the investigators record electroencephalogram (EEG) brain activity. Then, the investigators will ask the participants to report which items the participants remember seeing. The investigators will examine how the measured brain activity relates to which pictures the participants remember.

Electrophysiological signatures track distinct subprocesses of working memory, including the number of items and the spatial locations of those items. By identifying how these subprocesses predict long-term memory success in healthy young adults, this project should lead to an intricate understanding of the relationship between working memory and long-term memory. This study will investigate when and how long-term memory failures arise, by using sophisticated machine learning analyses of neural data. Moreover, this study will test the extent to which the investigators can track working memory processes in real time and how the investigators can leverage that information to improve long-term memory success. This will inform basic theories of the relationship between working memory and long-term memory and motivate future applications.

Eligibility Criteria:
Inclusion Criteria:

* normal or corrected to normal vision

Exclusion Criteria:

* non-fluent in English
Effects of Dry Needling on Spinal Mobility and Trigger Points in Patients With Fibromyalgia Syndrome.

This study evaluates the effect of Dry Needling on Spinal Mobility and Trigger Points in Patients with Fibromyalgia Syndrome.

Dry Needling is a skilled intervention that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points, muscular, and connective tissues for the management of neuromusculoskeletal pain and movement impairments. Dry needling (DN) is a technique used to treat dysfunctions in skeletal muscle, fascia, and connective tissue, and, diminish persistent peripheral nociceptive input, and reduce or restore impairments of body structure and function leading to improved activity and participation.

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia syndrome diagnosis.
* Aged from 18 to 65 years.
* No regular physical activity.
* Limitation of usual activities due to pain on at least 1 day in the previous 30 days.
* Agreement to attend evening therapy sessions.

Exclusion Criteria:

* Severe physical disability.
* Comorbid conditions (eg, morbid obesity, inflammatory diseases, irritable bowel syndrome, interstitial cystitis).
* Uncontrolled endocrine disorders (eg, hyperthyroidism or hypothyroidism, diabetes).
* Malignancy.
* Psychiatric.
* Illnesses (eg, schizophrenia or substance abuse).
* Medication usage other than as-needed analgesics (excluding long-term narcotics).
* History of surgery.
* History of whiplash injury.
* Presence of a score \>9 points in the Beck Depression Inventory.
The Effect of Milk Proteins on Satiety, Food Intake and Metabolic Control (Glycemia) in Early Adulthood

The purpose of this study is to develop and test modified milk protein products to determine the effects of amino acids on food intake, satiety, insulin secretion and glucose control by insulin-independent action in healthy adults.

1. A total of 33 males and females will participate in the study. Capillary blood samples will be collected from all participants to measure plasma glucose over a 3.5 hour postprandial study.
2. Intravenous blood samples will be collected from a subset of 12 (6 males and 6 females) participants for determination of insulin, satiety hormones, acetaminophen (gastric emptying rates), and determination of amino acid profiles.

Eligibility Criteria:
Inclusion Criteria:

* BMI 20 - 24.9 kg/m2
* Healthy as determined by screening questionnaire
* Male or Female
* Non-smoking
* Normal fasting plasma glucose (\<5.5 mmol/L), but not below 3.3 mmol/L.
* Prior use of acetaminophen

Exclusion Criteria:

* Gastrointestinal conditions or illness (including, but not limited to, lactose intolerance, Celiac, Crohn's, Ulcerative Colitis (UC), Irritable Bowel Disorder (IBD)
* Weight loss or weight gain of more than 5 kg during the previous 2 months
* Taking medication or protein supplements (excluding oral contraceptive, multivitamins and folic acid)
* Serious medical condition (ie. Renal, liver)
* Lack of appetite or skipping breakfast
* Restrained eaters as defined as having a Three Factor Eating Questionnaire-Cognitive Restraint \>16
* Smoking
* Reported intolerance to milk or very low consumption (\< 2 servings per week) as assessed by in-person screening. Or not liking of the research foods.
* Food allergies or intolerances as well as anaphylactic or life-threatening allergies - food or otherwise
* Diabetes or other metabolic diseases that could interfere with study outcomes
* Acetaminophen, codeine or opioid allergy
* Pregnant or Breast Feeding
* Typical alcohol consumption of not more than 4 drinks per sitting
To Study Different Levels of MK0493 for Safety, Efficacy, and Tolerability in Obese Patients (0493-017)(COMPLETED)

To study different doses of MK0493 for safety, efficacy and tolerability in obese patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient is between 21 and 65 years of age

Exclusion Criteria:

* HIV positive as determined by medical history
* Patient is pregnant, lactating or plans to become pregnant
* Patient has undergone surgical treatment for obesity
* Patient has undergone a surgical procedure within 4 weeks prior to Visit 1 or plans to undergo a surgical procedure during the study
* Patient plans to consume more than 2 glasses of grapefruit juice per day during the study
* Patient has participated in another clinical study (involving an investigational drug) within 3 months prior to restudy screening