cyrilzakka/clinical-trials huggingface dataset:
PET Scans in Normal Volunteers and Patients With Fabry Disease

This study will determine the rate of sugar metabolism in the brain of patients with Fabry disease, a genetic disease of abnormal lipid metabolism. Compared with healthy people, patients with Fabry disease have increased blood flow to the brain, which may result from abnormal brain metabolic activity. This study will use positron emission tomography (PET) and magnetic resonance imaging (MRI) to compare brain sugar metabolism in eight untreated patients, eight patients who are receiving enzyme replacement therapy, and eight healthy volunteers.

Patients with treated and untreated Fabry disease and normal volunteers may be eligible for this study. Participants will undergo the following two procedures:

1. PET scan \< The patient lies in the PET scanning machine. First, the chest is scanned for a few minutes to determine how much radiation the tissues of the chest absorb. A radioactive sugar called fluorodeoxyglucose (FDG) is then injected through a catheter (thin plastic tube placed in a vein) and the heart is scanned for about 45 minutes to measure the amount of FDG in the blood inside the heart. The head is then scanned for about 20 minutes to measure FDG in the brain. This measurement tells how much sugar the brain uses for energy. The procedure requires insertion of two or three catheters. A special facemask may be molded to the patient's head to help hold the head still during the scanning.
2. MRI scan \< The patient lies on a table surrounded by the scanner (a metal cylinder) for about 60 minutes. A strong magnetic field and radio waves are used to show images of structural and chemical changes in tissues.

This study may provide information that will help explain abnormalities in Fabry disease and the effect of treatment on the brain.

We have found that patients with Fabry disease have an increased resting global cerebral blood flow compared with healthy subjects. This augmentation may result from an abnormal metabolic activity in the brain of the patients. The goal of this protocol is to study the cerebral metabolic rate of glucose (rCMRGlu) in eight untreated patients with Fabry disease, eight Fabry patients who are receiving enzyme replacement therapy and compare it with the rCMRGlu eight in healthy volunteers. In order to minimize the need for arterial lines we shall image the left ventricle of the heart to obtain the (18)FDG time-activity curve needed to measure rCMRGlu. The method will be validated in the healthy volunteers.

Eligibility Criteria:
Hemizygote male Fabry patients 18-50 years-of-age.

Must be able to tolerate the procedures.

Must be able to give written informed consent.
Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body

The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of two Rotigotine patches of two different formulations


Eligibility Criteria:
Inclusion Criteria:

* Healthy White, male volunteers between 18 and 55 years of age (inclusive).
* BMI between 19 and 28 kg/m\^2 (inclusive)

Exclusion Criteria:

* Previous participation in a clinical study with Rotigotine
* History or current condition of epilepsy and/or seizures
* Known clinically relevant allergy or known/suspected clinically relevant drug hypersensitivity
* History of significant skin hypersensitivity to adhesives or other transdermal products or recently unresolved contact dermatitis
* History or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease
* Clinically relevant abnormality in physical examination, ECG, vital signs or safety laboratory examinations
* Positive HIV, hepatitis B or C test or positive alcohol or drug test
* Relevant hepatic or renal dysfunction
* Intake of medication that might interfere with the test drug within 2 weeks prior to dosing
Studying Genes in Samples From Younger Patients With Acute Lymphoblastic Leukemia

RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PURPOSE: This laboratory study is looking into genes in samples from younger patients with acute lymphoblastic leukemia (ALL).

OBJECTIVES:

* To identify somatically acquired genetic copy number and sequence alterations at the time of diagnosis in adolescent and young adults (AYA) acute lymphoblastic leukemia (ALL) samples and to correlate them with clinical and laboratory characteristics and outcome.
* To identify specific microarray multi-gene and multi-exon expression signatures at the time of diagnosis and to correlate them with clinical and laboratory characteristics and outcome.
* To gain insights into the genetic events that contribute to the formation, development and relapse of AYA ALL by integrating the copy number and sequence alterations with the multi-gene signatures and by comparing these with data already generated in pediatric ALL.

OUTLINE: Cryopreserved samples are analyzed for DNA copy number alterations and loss-of-heterozygosity, gene expression profiling, and mutation analysis by single nucleotide polymorphism (SNP) microarrays, Affymetrix Exon arrays, and whole genome amplification (WGA, Repli-G Qiagen). Confirmation studies are then done by fluorescence in situ hybridization (FISH), reverse transcriptase (RT)-polymerase chain reaction (PCR), and rapid amplification of cDNA ends (RACE).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Samples from patients diagnosed with B-progenitor AYA ALL from:

  * The Children's Oncology Group high risk ALL Study AALL0232 (age 16-21)
  * The St. Jude Children's Research Hospital (SJCRH) Total XV studies (age 16-21)
  * AYA ALL (from patients 22-30 years of age and from patients age 31-39 years) existing in the ALL Tissue Repositories of the adult National Cancer Institute (NCI) Cooperative Oncology Groups

    * The Cancer and Leukemia Group B (CALGB)
    * The Eastern Cooperative Oncology Group (ECOG)
    * The Southwest Oncology Group (SWOG)
* Cryopreserved viable leukemic cell suspensions, obtained from bone marrow or peripheral blood at pretreatment and initial diagnosis
* Matched normal (germline) samples from end induction-remission bone marrow or blood samples or from buccal swabs, if available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Minnesota Healthy Brain Initiative

Minnesota Healthy Brain Initiative will be an ongoing project that aims to increase awareness regarding brain health and its maintenance as well as increasing awareness of the impact of alcohol on brain function. In the immediate future, we hope to obtain data from a non-injured normative, diverse population represented by the state fair patrons.

We hypothesize that a non-invasive 30-minute test, requiring a subject to complete questionnaires and watch images on a TV screen, will yield information relevant to both diagnosis and prognosis of neurological state. To clarify, these tests will not produce information that would involve a diagnostic finding for the participants. We will measure eye movements under a range of visual conditions, including saccades, fixations, smooth pursuit, scan paths and optico-kinetic nystagmus

After receiving proper introduction and signing the proper consent forms, the subject will receive instructions to carry out cognitive assessments and answer verbal questionnaires. The subject will also undergo eye tracking. In order to validate the data collected by our eye-trackers, we may ask the subject to complete a non-invasive vision assessment and a breathalyzer assessment. Due to the nature of the breathalyzer assessment, we have decided not to administer the breathalyzer assessment to subjects who are under the age of 21 and/or pregnant. We also refuse to disclose the results of the breathalyzer assessment to the subject since the data will be collected only for research purposes. Subjects' eye movements will be tracked binocularly at a fixed distance from a computer monitor over a brief time period. The visual stimuli will be video clips appropriate for a general or pediatric audience. If at any point the subject becomes uncomfortable, the procedure will be aborted and can be resumed at a later time.

Eligibility Criteria:
Inclusion Criteria:

Males and Females Ages 4-100 All racial and ethnic origins will have an opportunity to participate

Exclusion Criteria:

Blind in one or both eyes Unable to open eyes Unable to detect light in either eye
Placebo Controlled Clinical Trial of the Postoperative Opioid Sparing Effects of Intraoperative Dexmedetomidine Infusion for Thoracic Surgery

The purpose of this study is to see if the drug, Dexmedetomidine (also known as Precedex), can reduce pain for patients having Thoracic Surgery and therefore reduce the amount of opioid drug needed after surgery. It is a drug that is already approved by the FDA (Food \& Drug Administration) for use as a sedative in hospitals and is currently used in the investigators Intensive Care Unit for this purpose. The investigators want to investigate if it also has pain relieving properties.

The study involves the use of dexmedetomidine infusion intraoperatively during thoracic surgical procedures (not using an epidural) with discontinuation in the immediate postoperative period. A key feature in this study is to employ the drug infusion intraoperatively only.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ( ≥ 21 years old) scheduled for Thoracic Surgery

Exclusion Criteria:

* 2nd or 3rd degree heart block as assessed by preoperative EKG
* Use of dexmedetomidine within 28 days prior to day of surgery
* Use of long acting opioids pre-operatively 28 days prior to day of surgery
* Current or past diagnosis of a Major Psychiatric disorder precluding adequate outcome responses such as Schizophrenia, dementia, delirium etc. as recorded in the Pre-Operative Record.
* Documentation of congestive heart failure and Ejection fraction \< 30% if recorded in the Pre-Operative Record.
* Planned use of an epidural for surgery or post-operative pain relief
* Contraindication to use of NSAID, Acetaminophen or IV opioids.
* Any known hypersensitivity to dexmedetomidine
* Pregnant or breastfeeding
* Abnormal liver function tests as related to the MSK guidelines for use of IV Acetaminophen

Yes or NO?; Is ALT greater than 2 x Upper Limit of Normal (\> 75 U/L)?

* Abnormal renal function tests as related to contraindications to use of IV Ketorolac

Yes or No?; Is Serum Creatinine \< 1.5 mg/dl?
Prepectoral vs Partial Subpectoral Two-Stage Implant-Based Breast Reconstruction

The purpose of this study is to investigate the to analyze the patient satisfaction and complication rates under controlled conditions of the increasingly popular prepectoral technique for implant-based breast reconstruction.

This is a single center, single-blinded, randomized clinical trial involving adult women undergoing two-stage implant-based breast reconstruction for either breast cancer or breast cancer risk reduction. The aim is to generate high quality evidence before establishing the prepectoral technique as routine care. A favorable safety and patient satisfaction profile will bring high quality evidence supporting the adoption of a technique that has shown similar complication rates while eliminating animation deformity and its associated pain and discomfort in retrospective and non-randomized studies.

The mastectomy flap perfusion will be assessed clinically and using SPY fluorescence imaging. Immediately following mastectomy, participants will be randomized to one of two treatment arms.

Group A will be composed of participants who will undergo prepectoral reconstruction with Acellular Dermal Matrix (ADM) by means of the anterior tenting technique. In this technique, two sheets of contour, fenestrated ADM sutured together are trimmed in accordance with the measurement of the expander/implant and fixed to the pectoralis major muscle covering the entire anterior surface of the device

Group B (current standard of care (SOC)) will be composed of participants who will undergo partial subpectoral reconstruction with ADM by means of the sling technique. In this technique the leading edge of the pectoral muscle is elevated and a subpectoral pocket is fashioned. The lower medial origin muscle fibers are released for anatomical expander seating. An ADM sling is sutured from the leading edge of the pectoralis muscle to the inframammary fold (over the expander) and laterally to close the expander pocket.

Eligibility Criteria:
Inclusion Criteria:

- Undergoing two-stage implant-based breast reconstruction for either breast cancer or breast cancer risk reduction

Exclusion Criteria:

* Active use of any tobacco products
* Uncontrolled diabetes defined by HbA1c greater than 7.5%
* Class II obesity or higher defined by a body mass index equal or greater than 35 kg/m2
* History of radiation to the affect breast or chest
* Immunocompromised patients
* Clinical evidence of significant mastectomy flap ischemia prior to the initiation of the reconstructive procedure
Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in the Management of Acute Postoperative Pain

Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in patients after mini-abdominoplasty

This is a randomized, double-blind, study to evaluate the safety, PK profile of CPL-01 for the management of postoperative pain after mini-abdominoplasty surgery.

Eligibility Criteria:
Inclusion Criteria:

* Subject provides signed, written informed consent before participation in the study.
* Subject is aged ≥18 and ≤70 years at the time of informed consent and is male or female.
* Subject is scheduled to undergo elective mini-abdominoplasty surgery under general anesthesia without collateral procedures.
* Female subjects are eligible only if all the following apply:

  1. Not pregnant
  2. Not breastfeeding
  3. Not planning to become pregnant during participation in the study
  4. Committed to the use of an acceptable form of birth control for the duration of the study until at least 30 days after administration of IP.
* Male subjects must commit to the use of a reliable method of birth control for the duration of the study until at least 30 days after administration of IP or be surgically sterile (biologically or surgically).
* Subject is free of any physical, mental, or medical conditions which, in the opinion of the investigator, make mini-abdominoplasty or study participation inadvisable.

Exclusion Criteria:

* Subject has known, suspected, or reported history of alcohol or drug abuse or dependence within the previous 2 years as assessed by the investigator
* Subject has impaired liver function (e.g., aspartate aminotransferase/alanine aminotransferase greater than 3 times the upper limit of the reference range, bilirubin greater than 1.5 times the upper limit of the reference range unless due to Gilbert's syndrome, active hepatic disease, evidence of clinically significant liver disease, or other condition such as alcoholism, cirrhosis, or hepatitis, etc.) that suggests the potential for an increased susceptibility to hepatic toxicity with IP exposure.
* Subject has clinically significant renal abnormalities (creatinine ≥1.5 × upper limit of normal).
* Subject has hemoglobin A1c ≥7.0%.
* Subject has participated in another clinical study and/or received an IP (marketed or premarket) within 30 days before surgery.
* Subject has a history of, or positive test results for, human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus antibody at Screening.
* Subject with an upper respiratory infection/cough in the 14 days before surgery.
* Subjects with a history of significant postoperative nausea and vomiting.
Analgesic Effect of Adding an Adductor Canal Block to a Femoral Triangle Block for Total Knee Replacement

The aim of the study is to investigate whether the addition of an adductor canal block to a femoral triangle block will provide better analgesia for patients after total knee replacements.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total knee arthroplasty under spinal anaesthesia
* 45y or older
* ASA 1-3
* BMI 18-35

Exclusion Criteria:

* Unable to consent
* Chronic opioid consumption
* Allergy to study medication
* Lower limb surgery preceding year
* Unable to complete baseline testing, pre-existing neurological deficit
* Contraindication to spinal anaesthesia
Study of Axial Mobility Exercises in Parkinson Disease

OBJECTIVES:

I. Compare the benefit of exercise versus usual care (no exercise) on impairments and functional limitations in patients with Parkinson disease.

PROTOCOL OUTLINE: This is a randomized study. Patients assigned to the Axial Mobility Exercise Program participate 3 times a week for 10 weeks. The program consists of individualized exercises specifically directed toward restoration of axial mobility in the context of functional tasks.

Patients assigned to the control group receive standard care (no exercise).

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Stage 2 or 3 Parkinson disease (Hoehn/Yahr scale) Able to ambulate independently Able to function independently in home Moderate rigidity No moderate or severe tremor --Prior/Concurrent Therapy-- Concurrent stable pharmacologic regimen required --Patient Characteristics-- Cardiovascular: No unstable angina Other: No psychiatric or medical contraindication to exercise, e.g., dementia, hip fracture; no other neurologic disorder, e.g., stroke, multiple sclerosis; resides within 30 miles of Duke University
SDR Monitoring in Children With Cerebral Palsy

The study evaluates the anatomical distribution of the assessed Electromyogram (EMG) responses ensuring after sensory nerve root stimulation and obtained IOM grading during selective dorsal rhizotomy (SDR) with regard to level and, side of the body and gender as well as pain management and outcome data.


Eligibility Criteria:
Inclusion Criteria:

* Male and female children with spastic cerebral palsy undergoing selective dorsal rhizotomy surgery including intraoperative neuromonitoring

Exclusion Criteria:

* \> 21 years
The Effects of Walking in Nature (vs. an Urban Setting) on the Wellbeing of Postsecondary Students.

The goal of this randomized controlled trial is to examine the effects of a walking intervention (3 walks per week for a period of 4 weeks) in a nature vs. urban setting on the wellbeing of young adult postsecondary students. We will examine changes in positive and negative affect for participants assigned to the nature condition vs those assigned to the urban condition (primary outcome). We will also examine changes in reported depression and anxiety symptoms, perceived stress levels, sleep quality, mindfulness and wellbeing (secondary outcome).


Eligibility Criteria:
Inclusion Criteria:

* aged 18-25 years
* speaks English
* had working smartphone that can track walk routes using a smartphone application

Exclusion Criteria:

* inability to walk for 45 minutes due to serious medical reasons (eg surgery)
* heart condition
Holo CTO Proctoring Study

Assess Microsoft HoloLens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex CTO procedures

Proctoring in medicine is related to better outcomes. Specifically, in CTO PCI systematic proctoring has demonstrated improved success rates, and an increased ability to treat lesions that are more complex. Most likely, proctoring together with operator volume is one of the foundations to the introduction and execution of CTO procedures. Proctoring traditionally involves an expert operator (proctor), visiting the institution, performing the procedure together with the local operator. This involves increased cost, and current travel restrictions makes traditional one-on-one proctoring challenging.

This study aims to evaluate the Microsoft HoloLens as a potential platform in proctoring and effective real time communication between PCI operators located at different geographical locations. The proctor and the local operator interact using a head mounted mixed reality (MR) display, enabling the proctor to see the same image as the operator, from any distanced location.

Eligibility Criteria:
Inclusion Criteria:

Clinical inclusion criteria:

* Stable angina pectoris, or dyspnoea as an angina equivalent
* Age ≥18 yrs.
* Able to provide written informed consent

Angiographic inclusion criteria:

* One or more completely occluded coronary arteries with Thrombolysis In Myocardial Infarction (TIMI) flow 0. An estimated occlusion duration of at least 3 months
* Absence of Q-wave in ECG leads corresponding to the occluded vessel, or documented viability of the main territory by MRI or echocardiography

Procedural inclusion criteria:

* Clinical indication for CTO PCI regardless of operative technique

Exclusion Criteria:

* STEMI within 72 hours
* Cardiogenic shock
* Active bleeding or coagulopathy
* Life expectancy \< 2 years
* Relevant allergies (aspirin, clopidrogrel, ticagrelol, contrast compounds)
* Severe peripheral artery disease
* Clinical unstable angina
Pilot Suty of the Assessment of Food Preferences After Bariatric Surgery (BariaTaste Pilot)

More than 50,000 patients in France benefit from bariatric surgery every year. However, nutritional complications (protein malnutrition, hypoglycaemia) are common and primary or secondary weight failures (weight recovery) account for almost 20% of operated. Weight loss and the metabolic effects of surgery are not related only to a reduction in dietary intakes, but also to mechanisms independent of caloric reduction, such as eating behaviour after bariatric surgery (Gastric Bypass or sleeve gastrectomy). These choices are guided by perceived changes in the properties of the food, resulting in changes in tastes, palatability and more generally food preferences. Among available tools to evaluate dietary preferences we selected the Food Leeds Preference Questionnaire (FLPQ) to assess those modifications. During this test, photographs of food products classified according to predetermined characteristics are presented with different instructions and response design to estimate liking, wanted for food, implicitly or explicitly. Our main hypothesis is that the use of the Food Leeds Preference Questionnaire will highlight differences in dietary preferences according to the type of bariatric surgery performed.

We will be conducted a study observational study on three parallel groups: a control group composed of patients suffering from unoperated obesity, a group of patients operated for a sleeve gastrectomy and a group of patients operated for a gastric bypass. We will include 45 patients per group. The patients will have to pass the Leeds Food Preference Questionnaire (LFPQ). Our judgment criterion will be the degree of food preference assessed using the LFPQ. Participants will also be assessed on behavioural parameters with the Binge Eating Scale, the Yale Food Addiction Scale Version 2.0 and the Urgency, lack of Premeditation, lack of Perseverance and Sensation seeking Impulsive behavior scale (UPPS-P) short version.


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, between 18 to 65 years old
* Patient with a BMI between 18.5 and 60 kg / m2: minimum 35 kg / m2 for the obesity group
* Patient undergoing initial assessment before bariatric surgery for the obesity group
* Patient being assessed for follow-up after bariatric surgery (after sleeve gastrectomy or gastric bypass)
* Patient agreeing to participate in the study.
* Patient affiliated to a Social Security scheme or beneficiary of such a scheme

Exclusion Criteria:

* Patient with other psychiatric comorbidities, including a bipolar mood disorder or eating disorder
* Patient with food eviction, whether medical or cultural
* Patient with ongoing psychotropic treatment (except anxiolytic treatment)
* Patient unable to give his agreement, not mastering the French language,
* Patient under authorship or curators