cyrilzakka/clinical-trials huggingface dataset:
Acute Renal Injury Associated Contrast in Intensive Care Unit Patients

Generally, a contrast medium is used when performing a CT scan or radiographic tests such as angiography because it heightens image clarity and can increase diagnosis accuracy. Despite these advantages, contrast media can cause allergic reactions in the body or a decline in renal function. Therefore, they should be handled carefully and explained sufficiently to the patient. For intensive care patients, the use of contrast agents has been revealed as a major cause of acute renal damage, and many studies have investigated this complication by examining incidence rates and prevention strategies. Hypothesis: Among intensive care patients, the group in which a contrast medium was used will have a higher risk of renal function decline compared with the group in which a contrast medium was not used, and, hence, the use of contrast media becomes a cause of renal function deterioration. Categorizing patients with renal function decline according to the new RIFLE criteria can have an association with the prognosis of intensive care patients, such as hospitalization period and death rate, which can promote faster intervention.


Eligibility Criteria:
Inclusion Criteria:

* For the 5 years from January 2008 to December 2012, patients in whom a contrast medium was used in the intensive care unit were examined.

Exclusion Criteria:

* For the 5 years from January 2008 to December 2012, patients in whom a contrast medium was not used in the intensive care unit were examined.
External Trigeminal Nerve Stimulation for Drug Resistent Epilepsy

The purpose of this study is to evaluate the tolerability and safety of the NeuroSigma eTNS system.

This study evaluates the safety and tolerability of the NeuroSigma eTNS system for the treatment of drug resistent partial seizures.

Up to 20 subjects, ages 18 - 75, with partial epilepsy will be enrolled in an acute 4-week tolerability study at Olive View/UCLA Medical Center .......

Enrolled subjects will be asked to maintain an accurate seizure calendar, and will be seen at the initial visit, then at two and four weeks.......

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Partial onset seizures (complex partial or secondary generalized tonic-clonic)
* At least one seizure every three months
* No serious or progressive medical or psychiatric illness
* At least one complex partial or generalized tonic-clonic seizure in the last three months
* MRI or EEG consistent with localization-related or partial epilepsy
* Exposure to at least two anti-epileptic drugs at adequate doses
* Concurrent use of at least one anti-epileptic drug at adequate doses
* No change in anti-epileptic drug dose for at least 30 days prior to study enrollment

Exclusion Criteria:

* Vagus nerve stimulation (VNS)
* History of non-epileptic seizures
* Inability to maintain accurate seizure calendars (self or caregiver)
* Frequent use of benzodiazepines for seizure clusters defined as greater that four times per month
* History of facial pain or trigeminal neuralgia
* Pregnancy
Photobiomodulation on Neuropathic Pain and Sensation Post-mastectomy

The goal of this case study is to examine the effects of Photobiomodulation (PBM) on neuropathic pain and sensation post-mastectomy in one female participant. Neuropathic pain and somatosensation will be primary measures, along with strength, range of motion testing, and measures of quality of life in response to exposure to PBM for 6 weeks.

The goal of this case study is to examine the effects of Photobiomodulation (PBM) on neuropathic pain and sensation post-mastectomy in one female participant.

The main question\[s\] it aims to answer are:

* Will there be a difference in subjective neuropathic pain reported after application of PBM using red and near-infrared wavelengths?
* If a difference in symptoms is discovered, how many sessions were administered before such difference was noted?
* Will there be an observed difference in sensation assessment after application of PBM using red and near-infrared wavelengths?
* Will there be an observed difference on upper extremity mobility following application of PBM using red and near-infrared wavelengths?
* Will there be a subjective difference in quality-of-life following application of PBM using red and near-infrared wavelengths?

Participants will be asked to participate in:

1. Initial sensation, range of motion, strength, pain, and quality of life assessments.
2. Observation and demonstration of the PBM application with a study investigator present.
3. Application of the PBM device to both sides of the chest over the breast tissue for a total of 30 seconds 3 times a week for 6 weeks in the participant's home environment without a study investigator present.
4. Documentation of pain and skin observation/sensation after each treatment session.
5. Follow-up assessments of sensation, range of motion, strength, pain, and quality of life at the end of week 6 after all PBM treatments have been conducted.
6. Weekly monitoring of pain, and skin observation/sensation during weeks 7-10 in the absence of treatment intervention.
7. Follow-up telephone calls by a study investigator during weeks 7-10.

Researchers will compare pre and post assessment results of sensation, pain, range of motion, strength, and quality of life for any changes as a result of the PBM therapy.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Status-post mastectomy due to clinical diagnosis of breast cancer
* Physician approval for participation in study
* Independent with all mobility
* Independent with cognitive decision-making

Exclusion Criteria:

* Active Malignancy
* Active Infection
Hedonic Perception and Brain Activity Response to Meal

The purpose of this study is to determine the relationship between brain activity and the perception of subjective hedonic sensations in response to a meal using functional MRI.

Functional MRI brain imaging will be performed in patients with functional dyspepsia and healthy controls in basal conditions and after a palatable test meal. During the study, the cognitive response and the hedonic dimension will be measured using 10 score scales.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80 yrs
2. Body mass index between 18-30 Kg/m2
3. Right-handed

Exclusion Criteria:

1. Subjects with clinical history of eating-disorders
2. Subjects with clinical history of significant head-trauma
3. Subjects with known serious illness: clinically significant cardiac, vascular, liver, pulmonary, or psychiatric disorders (as evaluated by the Investigator).
4. Subjects with a known history of alcohol or drug abuse in the previous 6 months.
5. Subjects using medications with SNS effects that cannot be discontinued, such as: antidepressants, pregabalin, gabapentin.
6. Women that are pregnant or that are breast-feeding.
7. Claustrophobia
LMA Protector Cuff Pilot vs LMA Supreme Among Anaesthetised, Non-Paralysed Patients

Comparison of clinical performance between LMA Protector Cuff Pilot and LMA Supreme in terms of oropharyngeal leak pressure, time to insertion, ease of gastric tube insertion, laryngeal view, incidence of sore throat


Eligibility Criteria:
Inclusion Criteria:

* Patients planned for general anaesthesia without muscle relaxant usage via supraglottic airway device.

Exclusion Criteria:

* BMI \> 35
* Patients with likelihood of difficult intubation (Simplified Airway Risk Index Score of 4 or more)
* Patients with increased risks of aspirations (gastrooesophageal reflux disease, obstetric patients, hiatus hernia)
Healing Hearts Together: Evaluating a Couples-based Intervention to Improve Health Outcomes

The purpose of this study is to test the efficacy of the 8-week Healing Hearts Together (HHT) program to improve relationship quality, mental health, quality of life (QoL), and cardiovascular health. This is a randomized controlled trial in which couples are randomly assigned to the HHT group or usual care. Changes in the outcomes of interest will be assessed at the end of the intervention (8 weeks) and 6 months later.


Eligibility Criteria:
Inclusion Criteria:

1. University of Ottawa Heart Institute (UOHI) patients and their partners
2. Participants in a romantic relationship who are cohabiting (married, common-law or committed relationship for ≥1 year). No restrictions will be placed on sexual orientation.
3. Participants are ≥ 18 years of age
4. Participants are able to read and understand English (HHT materials are only available in English; once efficacy has been established, all materials will be translated to French).
5. Patients and partners are available to participate for the next 6 months (intervention and follow-up).
6. Patients and partners are able to provide informed consent.

Exclusion Criteria:

1. Participants who, in the opinion of the study psychologist, manifest psychiatric illness or cognitive impairment that would preclude participation in HHT (i.e. unable to benefit from the intervention; to prevent disruption of other participants).
2. Participants who are engaging in couples therapy or plan to engage in couples therapy in the next 6 months.
Eligard Observational Registry for Patients With Prostate Cancer

The objective of this registry is to collect data on patient demographics, medical history, change in prostate, bone and overall health of the patients receiving androgen ablation treatment using Eligard. Data collected through this national registry program provides an opportunity to increase knowledge of efficacy and safety of the long term treatment with Eligard, provide a platform to better identify patient segments for the therapy with Eligard®. Furthermore registries are the only tools to accurately capture rare adverse events.

354 patients were enrolled in this study. Only 88 patients completed the study.

For those patients completing the three years of data collection, 10% were considered Castrate Resistant and remained on Eligard®. For those patients not completing 3 years of follow-up, 8.8% were considered Castrate Resistant and did not continue in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age.
* Histologically confirmed diagnosis of locally Advanced or Metastatic Prostate Cancer.
* Patient starting an androgen deprivation therapy with Eligard at 3 or 4 month treatment frequency per standard of care.
* Signed written informed consent.

Exclusion Criteria:

* Prior ADT (within 6 months).
* Any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol.
* Life expectancy less than 2 years.
Reliability Study of a Motor Function Measure Digitalized Playful Completion Modules

Neuromuscular diseases include more than 200 rare disorders affecting muscles or the nervous system. Functional scales assessing motor function are tools allowing to measure the evolution of motor impairment of patients with a neuromuscular disease. They are frequently used as main outcome measures in clinical trials which are currently in full development thanks to advances in genetic and drug researches.

Among the available scales, the Motor Function Measure (MFM), a scale consisting of 32 items, had shown good metrological properties in terms of validity, reliability and sensitivity to change, regardless of the diagnosis and extent of motor impairment.

By exploring the potential of digital technologies applied to MFM, investigators created a completion module composed of animations with different playful and informative scenarios displayed on a digital tablet.

The main purpose of this project is to conduct a multicentre study to assess reliabilities of the MFM completed using the MFM-Play.

Expected benefits of this project are to improve the experience and the participation of the children to who is often imposed multiple assessments during the numerous follow-up visits of clinical trials, while maintaining good metrological properties of the MFM.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a neuromuscular disease confirmed by the clinic, electroneuromyography (ENMG), biology, muscular biopsy, or genetic
* aged ≥ 2 yo and ≤ 60 yo
* having been informed and not objecting to participating in the study (information and non-opposition of parents/holders of parental authority for minor patients)

Exclusion Criteria:

* participating in other interventional research with an exclusion period that is still ongoing or that may interfere with the results of this study
* having had surgery or illness impacting their motor function within the last 6 months
* having understanding and/or behavioral deficiencies preventing rigorous assessment
* Patient placed under legal protection (this includes guardianship, curatorship and safeguard of justice)
LANDMARC Study: a Study With Focus on Aorta Ascendens

Rationale:

Aortic diameter is currently used as a gold standard in international guidelines for prediction of aorta pathology (aortic aneurysm and aortic dissection). However, aortic diameter has proven to be insufficiently accurate for making decisions about well-timed preventive interventions. The LANDMARC study will take place in line with the FIBAA-bank ('Correlatie tussen cardiovasculaire FIBroseringsgraad en Aorta elongatie, dilatatie en Atria dilatatie (FIBAA-bank): een biobank \& databank onderzoek met focus op aorta en atria' (METC-number 2022-3164)), and aims to reveal the undiscovered relationship between WSS (wall shear stress) values and aortic strain. In combination with data from the FIBAA-bank, the LANDMARC study will provide more accurate information for future risk stratification models for cardiovascular pathology (with focus on aortic disease).

Objectives:

Primary objective: indication of the association between WSS (peak WSS and WSS gradient) (through 4D-flow MR and CT) and aortic strain.

Secondary objective: indication of the association between (hemo)dynamic processes within the body (aortic elongation/aortic strain) and (patho-)physiological changes (degree of cardiovascular tissue fibrosis).


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Able to understand the trial and provide informed consent
* Patients who have participated in the FIBAA-bank

Exclusion Criteria:

* Patients with abnormal congenital cardiothoracic anatomy, with exception of presence of a bicuspid aortic valve
* Patients with history of chemotherapy, or radiotherapy within thoracic region
* Patients with an age \>80 years
* Patients with a weight \>120 kg
* Patients with a contra-indication for MRI according to the MUMC+ ODIN protocol nr. 004952
* Patients with impaired renal function (GFR \<30)
Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate)

This study will evaluate the behavioral effects of alcohol during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods.

Prior to the outbreak of the COVID-19 virus and subsequent work-from-home orders from the state of Kentucky government, participants completed five overnight sessions at theUniversity of Kentucky Inpatient Research Unit in the medical center. The protocol was then changed to have five sessions scheduled to be completed on an outpatient basis in the late afternoon/early evening. This protocol change was enacted following the resumption of research in the fall of 2020.

For both the inpatient and outpatient portions of this protocol, the first of these sessions was a practice session to familiarize participants with experimental procedures. The subsequent four experimental sessions were conducted following one-week maintenance on a methylphenidate dose (0, 20, 40, and 60 mg/day; within-subjects factor) over the span of four weeks. Participants were assigned to either an active duloxetine arm (60 mg/day) or placebo arm (between-subjects factor) also for the span of four weeks. The outcome measures collected were the same for both the inpatient and outpatient aspects of the study.

Subjects received 30 mg of oral duloxetine one time daily. Note: only 2 subjects were enrolled in this arm prior to the arm being removed in the summer of 2020. Data from this arm will not be reported in order to avoid any HIPAA violation due to the small number of subjects in this arm.

Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, visual inspection of their data revealed that their data was not appreciably different from participants in the 60 mg/day duloxetine arm. Therefore, we have added the data from these two participants to the 60 mg/day duloxetine arm for all reported data.

Eligibility Criteria:
Inclusion Criteria:

* able to speak/read English
* not seeking treatment at the time of the study
* one binge drinking episode (5+/4+ standard alcoholic drinks per drinking session for men and women, respectively) in the past 30 days
* recent alcohol use verified by ethyl glucuronide positive urine, as well as fulfillment of DSM-5 diagnostic criteria for alcohol use disorder
* ECG within normal limits
* otherwise healthy
* body mass index of 19-35
* females using an effective form of birth control and not pregnant or breast feeding
* judged by the medical staff to be psychiatrically and physically healthy
* able to abstain from alcohol for 12 hours prior to session

Exclusion Criteria

* Not under 21 years of age or over 55 years of age
* no contraindications/allergies to alcohol, duloxetine, or methylphenidate
Add-On Study of MSI-195 (S-Adenosyl-L-Methionine, SAMe) for Patients With Major Depressive Disorder (MDD)

The purpose of this study is to determine the efficacy and safety of 800 mg MSI-195 in reducing symptoms of depression in Major Depressive Disorder (MDD)patients with inadequate response to current antidepressant therapy.


Eligibility Criteria:
Inclusion Criteria:

* Meets the Diagnostic and Statistical Manual of Mental Disorder, 4th Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)
* A total score of 16 or higher on the Hamilton Rating Scale for Depression- 17 item version (HAM-D17) at the Screening and Baseline Visits, with a score of ≥2 on mood item 1.
* Have experienced 1-4 prior Major Depressive Episodes. Patients with more than 5 lifetime episodes (including current episode) will require discussion with the medical monitor prior to inclusion.
* Failed 1-3 treatment regimens in the current depressive episode
* Received an adequate dose and duration of Antidepressant Therapy (ADT) (on ADT for at least 6 weeks with a stable dose for at least 3 weeks)

Exclusion Criteria:

* Failed 4 or more adequate treatment regimens in current episode of depression
* patient may have a significant risk for suicidal behavior during the course of their participation in the study
* Intolerance to SAMe; Prior use of MSI-195
* History of any of the following psychiatric disorders: eating disorder within 6 months; obsessive compulsive disorder, psychotic disorder, bipolar disorder, mental retardation, dementia or other forms of cognitive impairment at any time or alcohol or substance abuse
* \>3X upper limit of normal (ULN) Alkaline Phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT); \>1.5X ULN total bilirubin
* Pregnant or lactating women
* Any history of seizures, excluding febrile seizures
* Known positivity for human immunodeficiency virus
Accuracy of Non-invasive Blood Pressure Monitoring at the Wrist in Obese Patients

Arterial blood pressure (ABP) monitoring is a corner stone in perioperative management. However, proper control of SBP requires accurate measurement of ABP.

The aim of this work is to validate the wrist OBP monitor in obese patients and compare it to upper arm location (in accuracy, convenience, and trending) using invasive blood pressure monitor as a reference standard.

Arterial blood pressure (ABP) monitoring is a corner stone in perioperative management. Recently, tight intraoperative individualized control of systolic blood pressure (SBP) (within 10% of baseline reading) was reported to reduce the risk of postoperative organ dysfunction in high risk patients undergoing abdominal procedures. However, proper control of SBP requires accurate measurement of ABP.

The gold standard for ABP measurement is through a catheter placed in an artery. Being an invasive, measurement of BP through an arterial catheter is restricted to patients with rapid major fluid shifts. Many indirect methods are used for measurement of ABP. Oscillometric blood pressure (OBP) monitoring is considered the standard non-invasive monitor for use in most clinical situations. In OBP monitor, a pressure transducer located in the cuff senses the series of small oscillations heart-beat induced pulse volume changes. These oscillations are detected during deflation of the cuff pressure from above the SBP to diastolic blood pressure (DBP).

The upper arm is the standard location of application of the blood pressure cuff as it is aligned with the heart level regardless the patient position. In obese patients, OBP monitoring is considered superior to auscultatory method which is limited by faint auscultatory sounds. However, application of blood pressure cuff at the upper arm in this population is frequently limited by large arm circumference and asymmetrical arm contour. Thus, locating the cuff at the wrist might be a more feasible alternative for the upper arm. OBP monitoring at the wrist was previously compared to auscultatory measurement of ABP in non-surgical patients. A recent study investigated the accuracy of OBP at the upper forearm in obese patients. No data to the best of our knowledge validated OBP monitoring at the lower forearm in obese patients using invasive blood pressure monitor as a reference standard.

The aim of this work is to validate the wrist OBP monitor in obese patients and compare it to upper arm location (in accuracy, convenience, and trending) using invasive blood pressure monitor as a reference standard.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged above 18 years)
* obese (with body mass index above 30 Kg/squared meter)

Exclusion Criteria:

* Peripheral vascular diseases
* Upper limb operations
* Upper limb scars
* Upper limb deep venous thrombosis
* Arrhythmias
SPECT Fibroblast Activation Protein Imaging in Patients With Cardiac Disease

This observational study aims to learn about the preliminary exploration of 99mTc-FAPI imaging in heart diseases and its potential application.

Participant involves patients with myocarditis, pulmonary hypertension, arrhythmia, myocardial infarction, dilated cardiomyopathy, and cardiac tumors, health conditions may also studied as control.

The main questions it aims to answer are 1, radionuclide 99mTc labeled fibroblast-activated protein inhibitors (99mTc-FAPI) imaging in the use of cardiac diseases and its limitations. 2, the performance in subjects with different control of hypertension to evaluate myocardial injury and fibrosis for providing a molecular biological basis for the study of diseases and mechanisms.

Participants will undergo 99mTc-FAPI imaging by Single-photon emission computed tomography (SPECT) and record their cardiac disease characterization and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis or suspected of cardiac injury
* Must be able to receive PET/CT scan

Exclusion Criteria:

* Pregnant women
* Severe claustrophobia