cyrilzakka/clinical-trials huggingface dataset:
Development of 3T Magnetic Resonance Research Methods for NIA Studies

Background:

- Magnetic resonance imaging (MRI) studies provide important information on the structure and function of various body systems, including the brain, muscles, joints, heart, and blood vessels. Scientific applications of MRI scans often use techniques that need to be modified or refined before they are used in clinical studies. To develop and modify these techniques for the new Philips 3T Achieva whole-body MRI scanner, researchers are interested in conducting trial MRI scans on healthy individuals and individuals with conditions that require imaging studies.

Objectives:

- To conduct preliminary trials of the 3T MRI facility to develop and refine MRI scanning procedures.

Eligibility:

- Individuals at least 18 years of age who are able to have magnetic resonance imaging.

Design:

* Participants will be screened with a full medical history and physical examination, as well as blood and urine tests.
* Participants will have an MRI scan using the 3T scanner. Some scans may require the use of a contrast agent or radiotracer, which is a small amount of radioactive substance that will be injected before the start of the scan. Some participants may be asked to perform tasks of thinking and movement while in the scanner, in order to test the procedures required for a functional MRI scan.
* No treatment will be provided as part of this protocol.

Study Description:

The purpose of this protocol is to permit use of the magnetic resonance imaging (MRI) facility for the development and refinement of MRI and spectroscopy (MRIS) scanning procedures. The information obtained through these methodological assessments will be essential future clinical research investigations conducted through the NIA under specific protocols. Additionally, this data can be utilized in already approved NIA studies for comparison purposes.

Objectives:

Primary Objective: To develop and refine specific MR imaging and spectroscopy methods.

Secondary Objectives: To allow pilot tests of procedures for development and refinement of motor or cognitive activation paradigms.

Endpoints:

Development of noninvasive MR biomarkers to assess longevity, healthy longevity, physical disability, cognitive impairment, and frailty.

Eligibility Criteria:
* INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all the following criteria:

* Ability of subject to understand the study and stated willingness to comply with all study procedures.
* Male or female, age \> 18years.
* Able to speak and read English.
* Capable of providing informed consent.
* Subjects or persons identified by an investigator to have a condition of interest for exploratory studies as it relates to aging. These participants are not being scanned for diagnostic purposes.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

* Has condition and/or non-removable device contraindicated for MRI as per the MRI eligibility form.
* Weight \> 300lbs (MRI scanner weight limit)
* Is currently pregnant or a nursing mother.
Comparative Effectiveness of Empagliflozin in the US

Empagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, was launched as a treatment for type 2 diabetes mellitus (T2DM) in the U.S. in August 2014. In contrast with several previous cardiovascular outcomes trials, which failed to demonstrate an association with a higher or a lower risk of cardiovascular outcomes associated with members of other recently marketed antidiabetic classes, the EMPA-REG OUTCOME trial has shown that patients at high cardiovascular risk randomized to empagliflozin vs. placebo, were associated with a reduced risk of hospitalization for heart failure, cardiovascular mortality, and all-cause mortality.

However, these and other findings arising from an extensive clinical trial program aimed at evaluating the efficacy and safety profile for empagliflozin have yet to be demonstrated in a non-trial environment. This study aims to investigate the transferability of the effects demonstrated in dedicated randomized clinical studies to a broader population under real world conditions.


Eligibility Criteria:
Inclusion criteria:

* Patients \>= 18 years old for Marketscan and Optum, and \>=65 years old for Medicare only
* Patients initiating empagliflozin or a DPP-4 inhibitor within the study period. Initiation was defined as no use of SGLT-2 inhibitors (canagliflozin, dapagliflozin, ertugliflozin) or DPP-4 inhibitors in the previous 12 months.
* Restriction to patients with a diagnosis of T2DM (ICD-9 Dx code of 250.x0 or 250.x2; ICD-10 Dx code of E11.x) in the 12 months prior to drug initiation.

Exclusion criteria:

* Patients with missing or ambiguous age or sex information.
* All patients who have less than 12 months of continuous registration in the database prior to initiation of empagliflozin or a DPP-4 inhibitor will be excluded.
* Patients with type 1 diabetes mellitus (T1DM) defined as at least 1 inpatient or outpatient codes in the 12 months prior to drug initiation.
* Secondary diabetes, and gestational diabetes in the 12 months prior to drug initiation
* History of cancer in the 5 years prior to drug initiation
* End-stage renal disease (ESRD) in the 12 months prior to drug initiation
* HIV diagnosis or treatment in the 12 months prior to drug initiation
* Organ transplant in the 12 months prior to drug initiation
* Patients that were in nursing homes in the 12 months prior to drug initiation
* Patients with concomitant SGLT-2 inhibitor and DPP-4 inhibitor initiation will also be excluded.
* Patients initiating more than one DPP-4i on cohort entry date will additionally be excluded Additional exclusion criteria apply.
The Role of AAT on DGE After Abdominal Surgery Based on RWS

Delayed gastric emptying (DGE) after surgery mainly occurs after gastrointestinal surgery A functional gastric emptying disorder, clinically characterized by weak or absent gastric peristalsis, gastric motility disorders, or gastric emptying Gastric retention, fullness, nausea and other uncomfortable symptoms caused by delay.This study is based on clinical diagnosis and treatment practice, observing, collecting, and analyzing Whipple surgery, pancreatectomy, and gastric cancer Perioperative data of subtotal resection surgery, mainly observing the diagnosis and treatment of ear acupoints in Whipple surgery, pancreatectomy, and subtotal gastrectomy.The application effect of DGE after resection surgery, exploring the diagnosis and treatment of ear acupoints in Whipple surgery, pancreatic body and tail resection surgery, and Diagnostic value of perioperative related diseases in abdominal surgery such as subtotal gastrectomy, and collection of health records.By comparing and analyzing the ear acupoint information of patients with abdominal tumors, we aim to explore the ear acupoints of the volunteers. The possible relationship between image and resistance specificity and common tumors in the abdominal cavity.


Eligibility Criteria:
Inclusion Criteria:

- 1) Age range: 40-70 years old (40 ≤ y ≤ 70), gender is not limited. 2) Accept abdominal surgeries including Whipple's surgery, pancreatectomy, and subtotal gastrectomy.

3) The subjects/guardians are able to understand the purpose of the trial, demonstrate sufficient compliance with the trial protocol, and sign an informed consent form (ICF)

Exclusion Criteria:

* 1) Severe postoperative complications such as heart disease, pulmonary embolism, cerebral infarction, abdominal infection, and abdominal bleeding; 2) Patients with organic changes such as adhesions and obstructions indicated by imaging examinations such as gastrointestinal imaging; 3) The patient has damage, redness, bleeding, infection, and other conditions in both ears that are not suitable for ear acupuncture treatment.

Inclusion and exclusion criteria for the health group

Inclusion Criteria:

1. Age range: 40-70 years old (40 ≤ y ≤ 70), gender is not limited.
2. No history of abdominal surgery or tumor, and no significant abnormalities were found through abdominal imaging examination.
3. The subjects/guardians are able to understand the purpose of the trial, demonstrate sufficient compliance with the trial protocol, and sign an informed consent form (ICF).

Exclusion Criteria:

1. Symptoms of digestive discomfort such as diarrhea, constipation, and vomiting have been present for the past 30 days.
2. The patient has conditions such as damage, redness, bleeding, and infection in both ears that affect the assessment of ear acupoint information.
Mitral Valve Management During Septal Myectomy

Objective of the study: to evaluate whether alfieri technique improves clinical and hemodynamic results compared to transaortic mitral valve secondary cord cutting in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.

There is pilot prospective randomised study comparing immediate and early results of additional subvalvular mitral apparatus intervention versus additional alfieri stich in patients scheduled to septal myectomy for symptomatic obstructive cardiomyopathy.

Patients with proven hypertrophic cardiomyopathy and resting left ventricle outflow tract obstruction underwent septal myectomy. If patients were suitable for both surgical techniques, they were randomized to alfieri stich or secondary cord cutting. All surgeons were experienced at least 50 related procedures.

Eligibility Criteria:
Inclusion Criteria:

* Hypertrophic obstructive cardiomyopathy
* Left ventricle outflow tract gradient \> 50 mm Hg at rest
* Systolic anterior motion mediated mitral regurgitation

Exclusion Criteria:

* Intrinsic valvular heart disease
* Coronary artery disease
* Aortic disease
Better Classification of Respiratory Amyloidosis

The B-AR project is based on a retrospective analysis of amyloidosis typing and the identification of their amylogenic protein.This work should be able to unite many clinicians, including pulmonologists and pathologists around a rare disease that still suffers from insufficient data.

The B-AR study will highlight the interest of proteomic analysis of amyloidosis compared to their identification by immunostaining. The objective is to reduce diagnostic wandering and to improve patient management. The typing of respiratory amyloidosis will allow a better characterization of the disease and thus, to propose a dedicated therapeutic management.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient \> to 18 years with amyloidosis on a histological sample of the tracheobronchial or pulmonary tree.

Exclusion Criteria:

* Subject receiving state medical aid
* Subject deprived of freedom, or under a legal protective measure (example: patients under guardianship or curators)
Robot Therapy for Rehabilitation of Hand Movement After Stroke

A study will be performed where individuals with chronic stroke will be randomly assigned to receive 2 different dosages of robotic hand therapy. One group will receive 12 sessions of robot-assisted repetitive movement practice in the HEXORR robot over a 4-5 week period. A second group will receive 24 sessions of HEXORR therapy over a 8-10 week period.

The overall goal of the proposed work is to improve hand function after stroke. Adequate hand function is critical to a functional upper limb, and is often resistant to conventional therapeutic interventions. Many stroke survivors have residual ability to flex the fingers, but extension is often limited and impeded by increased passive stiffness in flexors, involuntary activation of flexors and inability to activate extensors. The rationale for this approach stems from the growing evidence that neuro-rehabilitation after stroke may be enhanced via the application of motor learning strategies within the context of repetitive movement practice. The key therapeutic aspects of these strategies are high repetition, volitional effort, and successful completion of tasks to prevent frustration. While these represent promising therapeutic strategies, they are limited to mildly impaired subjects who already have enough control of finger extension to tolerate high repetitions of grasp/release tasks without succumbing to fatigue and/or frustration. There is a very large population of stroke patients who don't fall into this category and often must rely on compensatory strategies. In these patients, repetitive task practice facilitated by a robotic device may be more effective than unassisted task practice.

Eligibility Criteria:
Inclusion Criteria:

1. a diagnosis of stroke more than 6 months prior to randomization
2. presence of voluntary hand activity indicated by a score of at least 1 on the finger mass extension/grasp release item of the Fugl-Meyer Test of Motor Function
3. adequate cognitive status, as determined by Mini-Mental Status Examination score \>24

Exclusion Criteria:

1. were under the influence of oral or injected antispasticity medications during the study
2. had MCP and IP passive extension limit \> 30 degrees from full extension
3. had pain that interfered with daily activities
4. had excessive tone in the fingers and thumb as determined by Ashworth scores \>=3
5. had severe sensory loss or hemispatial neglect as determined by clinical exam.
Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury

Patients who have suffered moderate to severe traumatic brain injury (TBI) frequently develop behavioural changes, which can have deleterious consequences on interpersonal relationships, social, family and professional reintegration. They are a source of difficulties (burden) for family and friends. Social cognition covers four functions: recognition of social cues; empathy; attribution of intentions to a third party, or theory of mind; and adjustment of social behaviour according to context. This study has two parts: 1/ Evaluation, using a cognitive approach, of the different components of social cognition after moderate to severe traumatic brain injury, and of its repercussions in daily life and on family and friends.

2/ Creation of a specific re-education method for the different modules of social cognition and study of its effectiveness.

First objective: to study in a systematic way in the same group of TBI patients the different domains of social cognition and the relationships between these different sub-domains in these patients, as well as the relationships between these deficits and the more global cognitive functioning (executive functions), and to evaluate their repercussions in daily life (activity limitations and participation restrictions).

Second objective: to develop and evaluate the effectiveness of a specific rehabilitation protocol for social cognition, adjusted to each profile, according to the disorders of the components of social cognition found in each patient. We make the hypothesis that not all patients will present homogeneous deficits and we also wish to bring elements of knowledge on the sub-domains of social cognition that can be "mobilized" by therapeutic means based on cognitive training adapted to each patient. The methodology envisaged is based on an experimental methodology in single repeated case studies, allowing a fine analysis of the architecture of the altered cognitive processes in a given patient and to adapt the rehabilitation protocol in an individualized way.

Eligibility Criteria:
Inclusion Criteria:

* Male or female of legal age,
* Having suffered a moderate to severe traumatic brain injury (Glasgow Coma Scale score of 3 to 12) at least 6 months after the trauma,
* Returned home at least 3 months ago,
* Having given their informed consent,
* Affiliated to the social security system

Exclusion Criteria:

* Psychiatric history,
* Persistent post-traumatic amnesia,
* Instrumental disorders that interfere with taking tests (aphasia, agnosia, neurovisual disorders),
* Mood disorders not stabilized under treatment,
* Patient refuses to participate in the study,
* Participation in another cognitive rehabiltation protocol,
* Pregnant or breastfeeding woman.
Cheek Cells - Non-invasive Fatty Acid Status Marker

Various biological materials have been investigated to determine dietary fatty acid intakes, such as plasma, erythrocytes, and adipose tissue. The applied techniques are invasive sampling methods and may have limitations in studies involving infants or young children. In 1985 the group of McMurchie suggested buccal cheek cells as a marker for dietary fatty acid intake; however fatty acid profiling in cheek cells has not been widely used yet.

In a clinical intervention trial a new method will be tested. The study will consist of two consecutive parts: A) a correlation study will investigate the relationship between established fatty acid markers (red blood cells (RBC), plasma) and the newly proposed markers (cheek cells) before and after intervention B) an intervention study will investigate the time depended implementation and steady state of docosahexaenoic acid DHA in plasma, RBC and cheek cells.

The participants will receive 520 mg DHA daily over a period of 30 days. Blood and cheek cell samples will be collected once prior to study commencement and regularly during intervention.

The proposed study aims at verifying cheek cell analysis results as a non-invasive marker for fatty acid profiling. This will be shown by correlation analyses of fatty acids in cheek cells, erythrocytes and plasma phospholipids. Furthermore, the time kinetics of DHA incorporation into cheek cells will clarify if cheek cell fatty acids can be considered as a short or long term marker.

The new non-invasive method is expected to be extremely valuable as a non-invasive approach for studying the fatty acid profile in human, including infants and young children. Therefore, it is of great interest to validate the new method in a clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy males and females
* Body Mass Index 20-23 kg/m2
* Average athletic activity

Exclusion Criteria:

* Fatty fish consumption \> 1 per week (salmon, mackerel, sardines, herring)
* Intake of fish oil 3 months prior to study commencement
* Weight reduction diet 4 weeks prior to commencement or during intervention
* Recent (3 months prior to study commencement) medication assumed to interfere with lipid metabolism. The only exception will be the birth control pill, if the same drug (active ingredient) is taken for 3 months prior to study commencement and during the course of the study.
* Abuse of alcohol or drugs
* Pregnancy
PET/MRI Perfusion and CT Perfusion in Solid Tumors

Diagnostic comparison between PET/CT and PET/MRI with integrated perfusion measurement in CT and MR. Study aim is to gain knowledge about additional value of CT perfusion and MR perfusion in solid tumors concerning tumor physiology, diagnostic accuracy and possibly prognostic.


Eligibility Criteria:
Inclusion Criteria:

* indication as stated above
* written informed consent
* patients with suspected or confirmed solid malignant tumors of the neck, chest or abdomen who have an indication for a PET/CT

Exclusion Criteria:

* pregnant or breast feeding women
* non compliance of the patient to follow the study instructions (e.g. hearing problems, dementia)
* Inclusion in another clinical trial 30 days prior to inclusion
* age \< 30years
* contraindication for MRI (cardiac pacemaker, certain metal implants, claustrophobia
* known allergies to contrast CT or MRI contrast media
* patients with an glomerular filtration rate of \< 60ml/min/1.73m2
Metabolic and Neuro-Endocrine Effect of Treating PCOS in Adolescents

To exam in the effect of a combination of low dose Metformin and Spironolactone on functional brain MRI, menstrual regulation and metabolism in adolescents with PCOS.

Polycystic Ovarian Syndrome (PCOS) is the most common endocrinopathy in adolescent females and also one of the most complex. Patients experience an exaggerated ovarian/adrenal androgen production in response to physiologic and supra-physiologic elevations in insulin. The hormonal dysregulation is not only associated with acne, hirsutism, and menstrual irregularity, but also with perpetuated insulin resistance, central adiposity, and clinical depression.

In the proposed study, we aim to treat a hormonally and metabolically well-defined group of adolescent girls with PCOS with a combination of two pharmacological agents: metformin (insulin sensitizer) and spironolactone (anti-androgen) for 6 months. Although hyperandrogenism is a fundamental component of PCOS and responsible for the perpetuation of insulin resistance, adiposity and anovulation, there are few pediatric studies that have examined the benefits of treating both insulin resistance and hyperandrogenism simultaneously. Preliminary studies in adults, however, suggest synergistic effect of both spironolactone and metformin (spiro-met) with near normalization of the metabolic and ovulatory dysfunction. Therefore, we hypothesize that spiro-met will improve adolescent metabolism, body composition, ovarian morphology/function. We anticipate that our study will generate key pilot data for further randomized, double blind placebo controlled trials using both agents.

We also plan to examine functional brain MRI before and after the spiro-met intervention. This will allow us to inspect the effects of the hyperinsulinemic/androgenic hormonal milieu in PCOS on structural and functional brain MRI. We hypothesis, that the hormonal environment in PCOS affects centers of appetite and mood.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy
* Meeting Androgen Excess Society (AES) diagnostic criteria of PCOS: Menstrual Dysfunction or PCO ovaries on ultrasound AND clinical or biochemical hyperandrogenism
* Normal liver and kidney function
* No chronic illnesses except for stable, treated hypothyroidism

Exclusion Criteria:

* Use of metformin and/or spironolactone within the last 6 months
* Currently on either oral hormonal contraception or other forms of hormonal contraception such as Depo-Provera, NuvaRing
* Current or past pregnancy
* Currently sexually active
* Psychiatric disorder based on self/parental report
* Type 2 diabetes (blood glucose \> 200mg/dl on OGTT)
* Anemia (Hct \< 35)
* Impaired kidney function (Baseline creatinine \> 1.0 mg)
* Abnormal liver transaminases \> 2 x the upper limit of normal range
* Potassium elevated outside the reference range (in non-hemolyzed blood sample)