cyrilzakka/clinical-trials huggingface dataset:
Safety, Parameterization, and Mechanism of Transcranial Focused Ultrasound

Through the BrainBox Initiative, investigators propose to study the effects of motor tFUS on Motor Evoked Potentials (MEPs) and GABA and Glutamate Concentrations in the Brain.

tFUS is an emerging neuromodulatory tool that uses pulses of low-intensity acoustic waves to stimulate deep brain structures such as the thalamus. tFUS has recently been used to probe deep brain structures in unresponsive wakefulness, pain, anxiety, and other neuropsychiatric conditions. However, tFUS is restricted mainly by use in the MR scanner environment, thus limiting session numbers by scan cost and participant comfort. Furthermore, with few human studies to date, the parameter space and mechanisms of action warrant further elucidation. Using novel focused ultrasound methods, investigators can stimulate at a minimum penetration distance of 20mm, uniquely enabling the study of the neuromodulatory effects of tFUS on cortical tissue. Specifically, investigators propose to study the effects of motor tFUS on motor-evoked potentials (MEPs) and GABA concentration. The proposed research is critical for understanding tFUS and advancing its therapeutic potential for future clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18-55
* Endorse good health with no history of mental or physical illness or implanted metal
* English as a primary language
* Capacity to consent
* Negative urine pregnancy test if a female of childbearing potential
* Willingness to adhere to the tFUS and MRI study schedule

Exclusion Criteria:

* Any psychotropic medication is taken within 5 half-lives of procedure time
* Any head trauma resulting in loss of consciousness
* Personal or family history of neurological illness or injury
* Alcohol or substance abuse or dependence (other than tobacco) in the past week
* Diagnosis or current treatment (pharmacological or otherwise) of any psychiatric condition
* Pregnancy
* Personal or family history of seizures or epilepsy
* Claustrophobia or inability to stay still in the MR scanner environment
* Any metal in the body
* Other contraindications to electrical or electromagnetic stimulation
* Hair in dreadlocks, braids, or weave
* Diagnosis of COVID-19 in the past 14 days
* Inability to adhere to the treatment schedule.
Effect of 60-days Saccharomyces Boulardii and Superoxide Dismutase Supplementation in Obese Adults

In animals it has been demonstrated that Saccharomyces boulardii decrease low-grade inflammation and fat mass; also Superoxide Dismutase (SOD) decrease low-grade inflammation. Therefore, the aim of this double-blind, placebo-controlled clinical trial was to assess the effect of a 60-days S. boulardii and SOD supplementation on circulating markers of inflammation, body composition, hunger sensation, pro/antioxidant ratio, hormonal, lipid profile, glucose, insulin and HOMA-IR, in obese adults (BMI 30-35 kg/m2).


Eligibility Criteria:
Inclusion Criteria:

* I class of obesity (BMI: 30-35 Kg/m2)

Exclusion Criteria:

* evidence of heart, kidney or liver disease
* diagnosis of major depressive disorder
* current medications for weight loss, for control of cholesterol and triglycerides
* anti-inflammatory treatments
* pregrancy of lactation
* type 1 diabetes mellitus, intestinal inflammatory bowel disease, celiac disease, chronic pancreatitis
* probiotic/prebiotic treatment in the last 4 weeks
* antibiotic use within the last 3 months
Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery

Acute kidney injury (AKI) is a common complication after cardiac surgery. Mismatch in renal oxygen demand-supply may be an important pathogenetic factor. Levosimendan has been shown to improve renal blood flow, glomerular filtration rate and renal oxygenation in healthy controls after cardiac surgery.

In order to investigate the effect of levosimendan in patients with AKI after cardiac surgery, the investigators plan a randomized placebo controlled trial. 30 patients will receive levosimendan or placebo. Renal blood flow and filtration fraction will be measured using infusion clearance technique of para-aminohippuric acid and Chromium ethylenediaminetetraacetic acid (Cr-EDTA) respectively.


Eligibility Criteria:
Inclusion Criteria:

* Patients in the cardiothoracic intensive care after cardiac surgery with cardiopulmonary bypass
* Acute kidney injury, defined as increase in S-creatinine 50% or 27 mol/L
* Normal S-creatinine before surgery

Exclusion Criteria:

* Ongoing treatment with inotropic drugs (not norepinephrine)
* Central venous oxygen saturation (ScvO2) \< 60% despite optimization of hematocrit and volume status
* Need of renal replacement therapy
* Ongoing bleeding
* Patient or next of kin does not consent with study participation
Alio WEAR Study: Long-term Wear of the Alio Platform

The WEAR study is long-term interventional study designed to evaluate patient and clinician use of the Alio platform, per its FDA cleared indications.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Receiving hemodialysis via an AVF or AVG in an arm location at the time of study start.
* Able to wear the SmartPatch effectively at the specified location on the arm.
* Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
* Willing and able to wear the SmartPatch as instructed and comply with all interviews, surveys and questionnaires, and schedule of evaluations.

Exclusion Criteria:

* Skin near the proximity of the AV access that is chronically swollen, infected, inflamed, open wounds, lesions, or has skin eruptions.
* Participation in any other clinical trials involving investigational or marketed products that in the opinion of the investigator could affect the quality of the data.
* Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
Making HD Voices Heard

The Pilot Study, Making HD Voices Heard, will ask people living with HD to report what they experience and how they function.

The Huntington Study Group (HSG) myHDstory™ Platform is an online, observational research platform that will host the Pilot Study, Making HD Voices Heard. The Pilot Study will ask people living with HD to report what they experience and how they function. Participants will provide self-reported information using their own compatible smartphones, laptops, desktops, or tablets. Participants will be asked to reply to a series of questions, including open-ended questions that will be transcribed by voice (microphone voice-to-text transcription) or keyboard-entered text to record what they experience in their own words.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 years and older
* Willing and able to provide informed consent electronically.
* Individuals answering as a participant must self-report they have been diagnosed with HD by a doctor.
* Ability to answer online questions or direct someone else to enter answers for them.
* Ability to ambulate independently and take care of some of his or her personal needs.
* Ability to read and understand English.
* Willing to create a unique identifier based on personal demographic information.
* Residing in the United States or its territories
* Owning or having access to an electronic device and secure internet connectivity

Exclusion Criteria:

An individual who does not meet all the inclusion criteria will be excluded from participation in this study.
Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) - Long Term Follow-Up

Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT 2)-Long Term Follow-up will follow participants enrolled in the Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) (NCT01167270) study from age 3 years through the developmentally important time at school-entry around age 6 years and into middle childhood at age 9.

INSIGHT(NCT01167270) is a randomized, clinical trial evaluating a responsive parenting (RP) intervention designed to prevent rapid infant weight gain and childhood obesity among first-born infants. RP has been shown to promote a range of adaptive outcomes in children including secure attachment, cognitive development, and self-regulation of emotions and behavior with the potential for many beneficial effects including obesity prevention. INSIGHT's RP intervention is being compared with a home safety control intervention using a birth cohort of 279 infants and parents who received four home visits during the first year followed by annual clinic visits through age 3 years.

The study team will now follow the INSIGHT cohort with growth measurements from ages 5-9 years and with an in-depth assessment of parenting and child behaviors around the time of grade school entry at age 6. The study extension is observational and participants will not be given any further parenting or safety guidance as described in the initial grant.

Eligibility Criteria:
Inclusion Criteria:

* Participating in the INSIGHT study.

Exclusion Criteria:

* Unwilling to continue study participation for the study continuation.
Lasmiditan Compared to Placebo in the Acute Treatment of Migraine in Korean

A randomized, double-blind, placebo-controlled parallel group study to evaluate efficacy and safety of lasmiditan tablet compared to Placebo in the acute treatment of Migraine


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give written informed consent.
* Male or female, aged 18 years or above.
* Participants with migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1 (International Headache Classification (ICHD-3).
* History of disabling migraine for at least 1 year.
* Migraine Disability Association (MIDAS) score ≥11.
* Migraine onset before the age of 50 years.
* History of 3 - 8 migraine attacks per month (\< 15 headache days per month).
* Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).
* Able and willing to complete an electronic diary to record details of the migraine attack treated with study drug.

Exclusion Criteria:

* Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the participant unsuitable for the study.
* Pregnant or breast-feeding women.
* Known hypersensitivity to lasmiditan or to any excipient of lasmiditan oral tablets, or any sensitivity to lasmiditan.
* History or evidence of hemorrhagic stroke, epilepsy or any other condition placing the participant at increased risk of seizures.
* History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo (BPPV), Meniere's disease, vestibular migraine, and other vestibular disorders.
* History of diabetes mellitus with complications (diabetic retinopathy, nephropathy or neuropathy).
* History within the previous three years or current evidence of abuse of any drug, prescription or illicit, or alcohol.
* History of orthostatic hypotension with syncope.
* Significant renal or hepatic impairment.
* Participant is at imminent risk of suicide (positive response to question 4 or 5) on the Columbia-Suicide Severity Rating Scale (C-SSRS) or had a suicide attempt within six months prior to screening.
* Participation in any clinical trial of an experimental drug or device in the previous 30 days.
* Known Hepatitis B or C or human immunodeficiency virus(HIV) infection. History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (e.g. hemicranias continua, medication overuse headache) where headache frequency is ≥15 headache days per month.
* Use of more than 3 doses per month of either opiates or barbiturates.
* Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within three (3) months prior to Screening/Visit 1.
Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction

The purpose of this study is to determine whether brief periods of ischemia performed just at the time of reperfusion -postconditioning- can reduce coronary endothelial dysfunction and infarct size in humans

Desobstruction of the culprit artery after acute myocardial infarction allows to reduce the consequences of prolonged ischemia. However, it is now clearly established that reperfusion induces by itself severe myocardial injuries. Postconditioning has been described as an adaptive response triggered by a brief ischemia applied after a prolonged coronary occlusion. Several teams have reported that ischemia/reperfusion cycles allow to reduce infarct size in experimental models.

Different pathophysiological processes have been proposed to explain the beneficial effect of postconditioning. It has been reported that postconditioning reduces the inflammatory response, and activates cardioprotective signaling pathways (Akt, eNOS, p70S6K). In addition, an improvement of the endothelial function has been reported.

This controlled trial aim to study the potential beneficial effect of postconditioning in patients with acute myocardial infarction. Forty six patients will be included in the study and the culprit artery will be reoccluded three times for 1 minutes after desobstruction in one of the both groups after randomization of the patients.

The evaluation will be focused on the comparison of the coronary reserve after intracoronary adenosine injection. In addition, additional parameters will be used to study the effect of postconditioning on post-ischemic endothelial dysfunction: frequencies of low reflow and slow reflow situation, myocardial blush and regression of ST elevation. The effect of postconditioning on the left ventricular systolic function will be studied by Doppler tissue imaging and RMN.

Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction (\<6 hours)
* Occlusion of a major coronary vessel

Exclusion Criteria:

* History of previous myocardial infarction
* History of Coronary Artery Bypass Grafting
* Need for Coronary Artery Bypass Grafting
* Stenosis not eligible for angioplasty
* Limited ischemic area
* Cardiogenic shock
* Interventricular septum rupture
* Mitral regurgitation\>2
* Ventricular tachycardia
* Atrioventricular block class II and III
Lcr35 / ICU / P. Aeruginosa

Preventing carriage of potentially pathogenic micro-organisms from the aerodigestive tract is an infection control strategy used to reduce the occurrence of nosocomial infections - including ventilator-assisted pneumonia - in intensive care units. The use of antibiotics is controversial and can lead to adverse effect such as the selection of highly resistant pathogens. The purpose of this study was to investigate the effect of oral administration of a probiotic strain, Lactobacillus, on gastric and respiratory tract colonisation/infection by Pseudomonas aeruginosa strains, according to the concept that an indigenous flora has a protective effect against secondary colonisation.

In this prospective double-blind randomised study, ICU patients receive twice a day either an oral dose of Lactobacillus casei rhamnosus, the available pharmaceutical form, or a placebo. Digestive tract carriage of Pseudomonas aeruginosa is monitored by cultures of gastric aspirates. The occurrence of respiratory tract colonisations / infections is monitored throughout the study. Evaluation criteria are the delay and the rates of gastric P. aeruginosa colonisation and respiratory tract infection or colonisation. Chi-square or two tailed Fisher exact test are used for comparing qualitative variables and Student's t-test or mann-Whitney test for quantitatives variables. The mean of non-acquisition expectancy (NAE), length of stay without P. aeruginosa acquisition, was calculated and P. aeruginosa non-colonized patient rates were estimated and the two groups compared with regard to survival curves from grouped data using the Kaplan Meier method and the Logrank test. Variables with a P. value ≤0.15 in the univariate analysis were included in a logistic regression and a Cox regression model for multivariate analysis.

Eligibility Criteria:
Inclusion Criteria:

* more than 18 years old
* length of stay longer than 48h
* with a nasogastric feeding tube

Exclusion Criteria:

* - less than 18 years old
* length of stay \< 48h
* immunosuppression
* absolute neutrophile count \< 500/mm3
* gastro-intestinal bleeding
* contraindicated enteral feeding
* positive P. aeruginosa gastric aspirates or respiratory tract specimens during the first four days after hospital admission
A Survey on the Role and Benefits of Online Social Networks on Filipino Patients With Psoriasis

With the rise of usage of the internet, online social networks have recently been gaining popularity. Joining these groups can be beneficial to patients with chronic medical illness, such as psoriasis.This was a cross-sectional online survey of psoriasis patients in the Philippines who are members of online support groups. The survey was conducted for a period of three months.The purpose of the research project was to describe the demographics, disease characteristics, activities and benefits of online support groups to Filipino patients with psoriasis. The extent to which members experience empowering processes and outcomes was also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of psoriasis
* individuals who are willing to complete the online survey
* proficiency in English
* membership in an online psoriasis support network

Exclusion Criteria:

* nonmembers
* unwilling to participate in the study
Intervention of Bladder Cancer by CAR-T

This is a Phase I/II and multicenter study designed to evaluate the efficacy and safety of 4SCAR-T cells in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have no further treatment available.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra)
2. Representative tumor specimens as specified by the protocol
3. Adequate hematologic and end organ function
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Life expectancy greater than or equal to (\>/=) 12 weeks
6. Measurable disease, as defined by RECIST v1.1

Exclusion Criteria:

1. Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
2. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
3. Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
4. Leptomeningeal disease
5. Malignancies other than UBC within 5 years prior to Cycle 1, Day 1
6. Pregnant and lactating women
7. Significant cardiovascular disease
8. Severe infections within 4 weeks prior to infusion
9. Major surgical procedure other than for diagnosis within 4 weeks
10. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
11. History of autoimmune disease
12. Prior allogeneic stem cell or solid organ transplant
13. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
14. Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis
Obesity in Sleep Medicine - Focusing on OHS Phenotypes

This study focuses on a comprehensive examination of obese patients with sleep-related breathing disorders including patients with OSA, sleep hypoventilation and OHS. The aim of this study is to (1) evaluate characteristics of and differences between severity levels of obesity-related breathing disorders, (2) discuss pathophysiological variables associated with hypoventilation during sleep or at daytime and (3) find functional parameters indicating sleep hypoventilation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* BMI ≥ 30 kg/m²
* Indication for sleep lab admission or indication for BiLevel or non-invasive ventilation therapy initiation due to existing hypoventilation/OHS

Exclusion Criteria:

* Age \<18 years
* Pregnancy, Lactation
* Any medical, psychological or other condition impairing the patient's ability to provide informed consent.
* Missing informed consent
* Participation in another clinical study
The Effect of Reiki Application on Stress and Anxiety Levels

The aim of this study is to determine the effect of reiki practice on stress and anxiety levels in nurses.

It was a randomized controlled trial. Reiki was applied to the participants in the experimental group twice a week for two weeks. No intervention was applied to the participants in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer nurses were included in the research

Exclusion Criteria:

* Nurses, who had previous reiki experience and did not agree to participate in the study, were excluded
Positron Emission Tomography - Computed Tomography (PET-CT) Cetuximab Project

Molecular imaging with positron emission tomography (PET) using \[18F\] fluorodeoxyglucose (FDG) has been suggested as an early, sensitive marker of tumour response to anticancer drugs by monitoring the changes in glucose metabolism in tumours. Recently, FDG-PET has shown to be highly sensitive in detecting early response in other tumours. In this study, the investigators will prospectively investigate the role of early FDG-PET (at day 7 and week 6) in outcome prediction.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven colorectal cancer
* Unresectable stage IV disease
* K-Ras wild type tumour
* Patients scheduled to undergo chemotherapy with irinotecan and cetuximab

Exclusion Criteria:

* Prior abdominal/pelvic radiotherapy, surgery or chemotherapy within 3 months prior to inclusion in the study
* Poorly controlled diabetes
* Concomitant serious illness, such as uncontrolled angina pectoris, myocardial infarction, heart failure, uncontrolled hypertension, infection
* Symptomatic brain metastases
* Pregnancy or participants of reproductive potential who are sexually active and not willing/able to use medically appropriate contraception