cyrilzakka/clinical-trials huggingface dataset:
A Study of the Kinetics of a 13C-Cholesterol Infusate in Healthy Male Subjects (0000-108)(COMPLETED)

This is a 2-part pilot study in healthy male subjects to evaluate plasma enrichment kinetics of \[13C3,4\]-cholesterol (Part I) and to assess the test-retest reproducibility (Part II) of Reverse Cholesterol Transport (RCT) measurements. The study will determine whether atom percent enrichment (% APE) at 18 hours can be extrapolated from the steady-state value and whether the mean difference in repeat Ra measurements is below is a prespecified level.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male 18 to 45 years of age at screening
* Subject has a stable weight (± 2 kg) for more then 6 weeks prior to screening

Exclusion Criteria:

* Subject has a history of ileal bypass, gastric bypass, or other significant condition associated with malabsorption
* Subject has an active or recent (\<2 weeks) gastrointestinal condition (gastroenteritis, diarrhea, chronic constipation, irritable bowl syndrome, etc.) affecting bowel movements
* Subject has a known allergy to beans, peas, eggs or egg-derived products and/or soy or soy-derived products
* Subject has a history of plant sterol storage disease (sitosterolemia, cerebrotendinotic xanthomatosis) or a history of intolerance to plant sterols and/or plant sterol containing products
* Subject has a history of hepatic or gall bladder disease (including gallstones, cholecystectomy, etc.)
* Subject is currently taking psyllium, other fiber-based laxatives, phytosterol margarines, and/or over the counter (OTC) therapies that are known to affect serum lipids
* Subject has taken lipid-lowering agents within 6 weeks prior to screening
* Subject has previously been administered an intravenous infusion of \[13C3,4\]-cholesterol
Hand Function for Tetraplegia

The purpose of this study is to evaluate the effectiveness of an implanted stimulator for providing hand function to individuals with cervical level spinal cord injury. The device stimulates the paralyzed muscles of the hand and forearm. The user of the device controls the stimulation by moving muscles that are not paralyzed, such as a wrist or neck muscle. The ability of the user to pick up and move objects, as well as perform various activities such as eating, drinking, and writing.

The overall object of this research is to provide restored functional abilities to individuals with cervical-level spinal cord injury through the use of an advanced wireless myoelectrically controlled battery-powered implanted neuroprosthetic system known as the "FIRSTHAND" System. This restored function can enable the individual to achieve greater independence in activities of daily living and an improved quality of life. Electrical stimulation of paralyzed muscles will be used to generate functional movements. The movements will be controlled using myoelectric signals generated from muscles under the subject's voluntary control. The specific hypotheses of this study are: 1) at least 75% of all subjects will be able to manipulate at least one more object in the Grasp-Release Test when using the advanced neuroprosthesis compared to without the neuroprosthesis. 2) At least 75% of all subjects will demonstrate an increased level of independence in at least one functional activity when using the advanced neuroprosthesis. 3) At least 75% of all subjects will demonstrate an average neuroprosthesis usage of at least three days/week.

Eligibility Criteria:
Inclusion Criteria:

* cervical level spinal cord injury;
* complete paralysis of fingers and thumbs;
* voluntary shoulder motion;
* electrically excitable forearm and hand musculature

Exclusion Criteria:

* extreme contractures of the joints;
* skeletal immaturity;
* extensive denervation in the forearm and hand;
* poor surgical risk
Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated with Proton Therapy

This study collects information on the side effects of proton therapy and detailed information on the proton therapy treatment plan itself. This may help researchers develop methods to predict the risk of side effects for future patients and learn the long-term benefit of proton therapy.

PRIMARY OBJECTIVES:

I. To prospectively collect data on acute and late toxicities (including second malignant neoplasms) in patients treated with proton therapy.

II. To collect and store the corresponding radiation dose distribution and imaging data in order to correlate normal tissue response with dose distribution.

SECONDARY OBJECTIVES:

I. To derive and refine dose-response relationships for normal tissue toxicity after proton therapy.

II. To document and compare symptom burden weekly during treatment and twice a month for 3 months after therapy, using the M.D. Anderson Symptom Inventory (MDASI).

OUTLINE:

Patients undergoing standard of care proton therapy are assessed for toxicities weekly during proton treatment, then from 1 to 3 times up to 90 days from the start of treatment and annually thereafter. Patients also complete questionnaires over 15-20 minutes at baseline, weekly during treatment, and every 2 weeks during follow up for up to 3 months.

Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for radiation treatment with protons at UTMDACC are eligible for this protocol
* Patients must sign a study-specific consent form prior to study entry

Exclusion Criteria:

* Patients who are unable or unwilling to attend the required periodic follow-ups either at M.D. Anderson or at a different site
Perfusion Pressure Cerebral Infarction Trial (PPCI)

STUDY HYPOTHESIS

In cardiac surgery the volume of perioperative cerebral infarctions can be reduced by increasing mean arterial pressure (MAP) during the cardiopulmonary bypass procedure.

BRIEF STUDY SUMMARY

Heart surgery using cardiopulmonary bypass (CPB) can be complicated by injury to the brain. Previous studies using brain scans have reported small stroke-like lesions in up to 51% of patients after cardiac surgery. However, only 1-6 % of patients have permanent symptoms of severe brain damage.

The majority of brain lesions seem to be caused by particulate matter (emboli) that wedge in blood vessels of the brain thereby compromising flow. In addition, insufficient blood flow to areas of the brain supplied by narrowed, calcified vessels may contribute. MAP during CPB usually stabilizes below the lower limit of cerebral autoregulation, which is accepted since sufficient total blood flow is guaranteed during CPB.

The aim of the PPCI trial is to investigate if increased MAP during CPB can prevent or reduce the extent of brain injury after cardiac surgery. A beneficial effect could result from reduced embolic injury through increased blood flow in collateral vessels and/or by increased blood flow in calcified arteries.

180 patients scheduled for cardiac surgery will be randomly allocated to increased MAP (70-80 mm Hg) or 'usual practice' (typically 45-50 mm Hg) during CPB, whereas CPB blood flow is intended equal and fixed in the two groups. Patients are examined before and 3-6 days after surgery with magnetic resonance imaging (MRI) brain scans, mental tests and by blood borne markers of brain injury.

If higher MAP during CPB is beneficial, a change of practice can easily be implemented in the clinical routine.

TRIAL DESIGN

The PPCI trial is a randomized, controlled, outcomes assessor and patient blinded, single-center superiority trial with two parallel groups in a 1:1 allocation ratio. The randomization will be stratified according to age (stratum 1 \< 70 years; stratum 2 ≥ 70 years) and type of surgery (stratum 1 - surgery involving the aortic and/or mitral valve; stratum 2 - surgery not involving these valves).

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age.
* scheduled elective or subacute cardiac surgery with the use of CPB.
* type of surgery either coronary artery bypass grafting (CABG) and/or heart valve surgery (provided that the valve prosthesis used is MRI compatible).

Exclusion Criteria:

* a history of stroke.
* a history of reversible ischemic deficits (duration of symptoms 24-72 hours)
* a history of transitory ischemic attacks (duration of symptoms \< 24 hours)
* diagnosis of neurodegenerative disorders such as Alzheimers, Multiple Sclerosis etc.
Study of Pregabalin in the Prevention of Central Neuropathic Pain in Acute Spinal Cord Injury

This research study will test to see if people who receive pregabalin after their spinal cord injury will develop less nerve damage pain than people who do not receive it.

Pregabalin is one of the few agents that have demonstrated effectiveness in the treatment of central NeP in SCI. Research is now proving that it is possible to prevent the development of pain in certain conditions. Pregabalin has been proven effective in this area with post surgical pain. Therefore, after traumatic SCI there may be a small window of time where we could prevent the development of NeP by administering an agent like Pregabalin.

Objective: To test the hypothesis that pregabalin is an effective treatment in preventing post-spinal cord injury neuropathic pain.

Design: double-blind, placebo controlled, randomized, trial Setting: Spinal cord injury program, neurosurgery and tertiary care rehabilitation center Subjects: 30 patients with acute traumatic spinal cord injury Method: Pregabalin will be offered to patients with acute traumatic spinal cord injury pain in a double blind crossover, placebo control design.

Main Outcome Measures: The primary outcome measures will be the development of Neuropathic Pain and intensity of pain Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores.

Results: To be determined. Conclusion: To be determined.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants will be 18 years of age or older
* Have suffered a traumatic spinal cord injury (complete or incomplete)
* Be free of Neuropathic pain
* Be in stable medical condition

Exclusion Criteria:

* Pregnant or lactating women: Because we do not know the risks of pregabalin in pregnancy, females of child bearing years must have a negative pregnancy test (performed on screening and subsequent follow up visits) and be using a reliable method of birth control including oral or injectible birth control hormones, barriers, intrauterine devices or tubal ligation, or abstinence throughout the duration of the study.
* Should a female become pregnant while participating in the study she will be un-blinded and, if on pregabalin, she will be weaned from the medication as quickly as is safe and withdrawn from the study. Appropriate follow-up for any pregnancy complications will be conducted.
* Persons with known hypersensitivity to pregabalin or its constituents
* Persons with Neuropathic pain at the time of enrollment
* Persons with a chronic pain diagnoses that may interfere with the evaluation of the presence of Neuropathic pain
Efficacy of Hand Exoskeleton Controlled by BCI in Post Stroke Patients

The purpose of this study is to assess the efficacy of non-invasive BCI-exoskeleton technology based on EEG patterns recognition matching to motor imagery in post-stroke patients with hand paresis.

The BCI training is based on EEG activity patterns recording during hand motor imagery. A subject sit comfortably 1m from a computer screen which presents visual instructions during the session. The robotic exoskeleton is fixed to the paretic hand. Subject visually fixate on a circle presented in the center of the screen and receive instructions from three surrounding rhomboidal arrows. Subject is given three commands instructing them to relax or imagine slow hand opening movement with the right or left hand. The "Relax" command means that the subject have to sit still and look at the center of the screen. Commands are presented randomly, each of 10 sec duration.

A visual cue provides the subject with feedback regarding the mental task recognition: the central circle turned green if the classifier recognizes the task in agreement with the given command, or remains white if the signal is not recognized. In addition to visual feedback the subject is provided with kinesthetic feedback: the exoskeleton is opening the hand when the classifier recognizes the imagery of paretic hand movement.

The EEG is registered with 30 electrodes distributed over the head in accordance with the standard international 10-20 system. EEG signals are filtered from 5-30Hz. A Bayesian approach for EEG pattern classifying is used in the system. The activity sources most relevant for BCI functioning will be identified using an independent component analysis (ICA). Classification accuracy will by measured with Cohen's kappa (Kohavi and Provost, 1998). The procedure may consist from up to three sessions, the duration of 1 session is 10 min, there are 5 min time brake between session and total duration of procedure is up to 45 min. The number of procedures - at least 10. The maximal interval between procedures is 3 days.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Medical history of primary acute cerebrovascular event (ischemic or hemorrhagic stroke) at least 4 weeks before screening
* focal stroke located in a hemisphere
* post stroke hand paresis (mild to plegia according to Medical Research Council (MRC) Scale for Muscle Strength)

Exclusion Criteria:

* Montreal Cognitive Assessment (MoCA) scale \< 22
* Left handedness
* Sensory aphasia
* Severe impairment of vision
* Modified Ashworth Scale (MAS) ≥ 4
Comparison of Intraoperative Hemodynamic Parameters and Arterial-blood Gas Changes at Two Different Pneumoperitoneal Pressure Values

Clinic and metabolic consequences of pneumoperitoneum, achieved by insufflation of gas carbon dioxide, are still debated. Cardiovascular system suffering due to the compression of intra-abdominal venous structures can cause life-threatening complications. Increased partial pressure of carbon dioxide induces metabolic acidosis with further vascular suffering. Pneumoperitoneum reduces the pulmonary exchange volumes and bring renal suffering.

Methods. The aim of this study is to evaluate the alterations in hemodynamic and hemogasanalysis parameters during the laparoscopic surgery at different pressure settings of pneumoperitoneum in order to assess the best pressure value.

We evaluated and compared intraoperative hemodynamic and hemogasanalytic alterations in two groups of patients respectively subdue to laparoscopic cholecystectomy at a pneumoperitoneum pressure of 12 mmHg (group A) and at a pressure of 8 mmHg (group B).

We evaluated intraoperative hemodynamic and hemogasanalytic alterations in two groups of randomized patients respectively operated at a pneumoperitoneum pressure of 12 mmHg (group A) and at a pressure of 8 mmHg (group B) to highlight any significant alterations.

The clinical sample used in the study is composed by patients aged between 15 and 85 years affected by cholelithiasis and treated with laparoscopic cholecystectomy in the period between July 2019 and February 2020.

20 patients, 9 men and 11 women, were enrolled. Group A included 10 patients, 5 men and 5 women, with an average age of 47.9 years. Group B included 10 patients, 4 men and 6 women, with an average age of 50.7 years.

The parameters evaluated were: heart rate (HR), average arterial blood pressure (BP), respiratory frequency (RF), oxygen saturation (SaO2), hemogasanalysis (PaO2, PaCO2, pH and HCO3-).

The measurements were made at four stages: before the induction of anesthesia, after the anesthesia induction but before incision, 30 minutes after the pneumoperitoneum induction, 5 minutes after the pneumoperitoneum releasing.

The hemodynamic parameters (HR, RF, BP, SaO2) were extrapolated from the multiparameter monitor for each evaluation. The hemogasanalytic values (PaO2, PaCO2, pH and HCO3) were evaluated by the radial arterial sampling. The average and standard deviation were calculated for the quantitative data normally distributed. For the comparison of the quantitative data, the t-student test was used. A value of p ≤ 0,05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria: cholelithiasis -

Exclusion Criteria: immunodeficiency disorders, chronic use of corticosteroids, non-compensated diabetes mellitus, major morbidity with a life expectancy of less than 30 days, significant anemia (hemoglobin \< 7 gr/Dl or hematocrit \< 21%), coagulopathies, ascites, chronic pain treatment, severe comorbidities

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Auto-antibodies Prevalence and CD1 Role in Gaucher Disease

Hypergammaglobulinaemia is frequently observed in type 1 Gaucher disease (GD1), being either polyclonal or monoclonal gammopathies. Polyclonal hypergammaglobulinemia may be related to the presence of autoantibodies. The clinical significance of such antibodies is questioned in Gaucher disease (GD), as some cases of immunologic thrombocytopenia and autoimmune hemolytic anemia have also been reported.

Objectives:

To evaluate the prevalence of autoantibodies and autoimmune diseases in GD1 patients, we conducted a multicenter national study. The investigators investigated whether there was a link between splenectomy, genotype, therapeutic options and the presence of these autoantibodies.They also investigated whether there was a correlation with some clinical manifestations of GD1


Eligibility Criteria:
for GD1 patients

Inclusion Criteria:

* Adult patients \>= 18 years old
* Gaucher disease type 1, proved by low betaglucosidase, with or without treatment
* Patients must have read, understood and signed informed consent.

Exclusion Criteria:

* Under 18 years old
* Pregnant or breast-feeding
* Patients under administrative control
* Prisoners
* Patients without social rights
* Emergency hospitalization
Filtered Eyewear to Prevent Light-induced Melatonin Suppression - Aim 1

The aim of this study is to determine the relative effectiveness of monocular and binocular light exposures, with and without selective blue-blocking filtering, on nocturnal melatonin suppression, subjective sleepiness, and visual performance of night shift workers.

Over the course of six, 5-hour study nights, 30 participants will be randomized to 6 study conditions, 1) binocular dim-light control unfiltered, (2) monocular dim-light control (one eye occluded), (3) unfiltered binocular, (4) unfiltered monocular (non-dominant eye occluded), (5) filtered binocular (both eyes filtered), (6) filtered monocular (non-dominant eye filtered, the other non-filtered). Saliva samples will be collected every 30 minutes for melatonin levels. Participants will also be asked to provide subjective sleepiness and visual performance will be assessed. Study nights will be separated by one week and each participant will be randomized to one of the six study conditions each night. All participants will see all conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Bipolar disorder
* Seasonal depression
* Diabetes
* High blood pressure
* History of cancer
* Obstructing cataracts
* Macular degeneration
* Diabetic retinopathy
* Glaucoma
* Use of melatonin supplements
* Use of beta blockers
* Use of sleep medications
* Use of antidepressant medication
Naïve HIV POC Monotherapy Trial

The primary objective of the trial is:

• to evaluate the change from baseline in plasma viral load with placebo and one of up to 4 dose regimens of RDEA806.

The secondary objectives are:

Efficacy

* to describe the nadir of the plasma viral load
* to describe the DAVG
* to assess the proportion of subjects who reached a drop in viral load of 0.5 log, 1 log, or reach an undetectable viral load
* to assess the plasma viral load decay rate
* to evaluate immunologic changes (as measured by CD4 and CD8 cells)
* to evaluate the genotypic and phenotypic pattern of the virus Pharmacokinetics
* to evaluate the pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of RDEA806 Safety
* to evaluate the safety and tolerability of bid and qd dosing of RDEA806 as monotherapy


Eligibility Criteria:
Inclusion Criteria:

* Documented chronic HIV-1 infection
* HIV-1 plasma viral load at screening visit above 5000 HIV-1 RNA copies/ml
* Male, aged above 18 years and less than 65 years of age
* Adequate method of birth control
* Subject has never received an antiretroviral agent (NRTI, NNRTI, PI, entry inhibitor or integrase inhibitor) for the treatment of HIV and agrees not to start antiretroviral therapy prior to enrollment or subject has only received a short course of treatment for less than 14 days and has been off treatment for at least 8 weeks
* Subject has no primary mutation in the reverse transcriptase (RT) gene associated with resistance to RT inhibitors and no major mutation in the protease gene associated with resistance to PIs determined by genotypic resistance testing at screening

Exclusion Criteria:

* History or suspicion of alcohol or drug abuse which in the Investigator's opinion may lead to non-compliance
* CD4 count \< 350 cells/mm3
* Life expectancy of less than 6 months
* Receipt of an investigational drug within 30 days prior to the trial drug administration
* Receipt of any vaccine within 30 days of screening visit
* Acute HIV-1 infection (seroconversion illness)
* Acute hepatitis A or acute or chronic hepatitis B or C infection
* Currently active acquired immune deficiency syndrome (AIDS)-defining illness (Category C conditions according to the Centers for Disease Control \[CDC\] Classification System for HIV Infection 1993)
* No clinically relevant laboratory abnormalities Renal impairment: serum creatinine \> 1.5 x ULN
* Febrile illness within 120 hours prior to dosing
* History of severe drug allergy or hypersensitivity
* Significant cardiac dysfunction