cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Percutaneous SPG Block in Aneurysmal SAH

Researchers are trying to develop alternative means to help patients with headache pain secondary to aneurysmal subarachnoid hemorrhage (bleeding about the brain).

This study is an open label, feasibility study that will consist of fifteen patients. This study will enroll only patients who have aneurysmal SAH that are secured by endovascular coiling. When a patient notes a severe headache which requires medical intervention on at least day 3 of the hospital admission, they will be asked if they would like to participate in an open label trial to use a bilateral SSPGB in addition to traditional medical management per unit protocol. The risks and benefits of the procedure will be explained to the patient. The patient will then either agree or disagree. If the patient disagrees, they will not be enrolled in the study. If the patient agrees, they will sign an informed consent and will be enrolled. Inclusion and exclusion criteria will be reviewed before enrolling a patient. The patients will first rate their pain from 0-10 on the numeric rating scale (NRS) (10 being the most severe). If their pain is at a level 5 or more and it is not responsive to traditional medical therapies, they will be a candidate for the study. The patients will receive bilateral injections as outlined below (5 mL: 4.5mL of 0.5% bupivacaine and 0.5mL of 10mg/mL dexamethasone on each side for total volume of 10 mL). Thirty minutes later and 24 hours following injection, the patient will rate their pain from 0-10 on the NRS. The description of the procedure is stated below. A success would be considered a drop in their pain score of at least 2.

Adverse effects will also be recorded 30 minutes after the procedure and the following day. Chart review on both provider and nursing notes will be performed on subsequent days to evaluate for adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Aneurysmal SAH in anterior/middle cerebral compartment
* Aneurysm must be secured endovascular with coiling
* The patient or patient's surrogate should be able to give informed consent and understand the risks of this study
* Pain NRS ≥ 5/10 in severity

Exclusion Criteria:

* Non aneurysmal, traumatic SAH
* Posterior fossa aneurysm ruptures
* Pregnancy
* Transcranial Doppler velocities suggestive of or approaching vasospasm
CareTaker Self-Calibration Validation

The goal of the study is to test the capability of the CareTaker monitor to calibrate its continuous blood pressure readings independently. Currently the device requires another approved blood pressure monitor to provide a starting calibration.

The new control module enables the CareTaker to perform a pressure sweep of the internal pressure in the finger cuff. The resulting data is analyzed using a combination of pulse analysis/oscillometry approach.

The specific objective of this project was to demonstrate the CareTaker's ability to perform self-calibration to the same performance standard as its predicate device. That device demonstrated efficacy by showing substantial equivalence to the performance of classical sphygmomanometry using a Riva-Rocci/Korotkoff (RRK) measurement on the brachial artery, meeting a bias of at least 5 mmHg and a standard deviation of 8 mmHg across 3 paired readings from at least 85 patients, for a total of at least 255 paired readings.

The study was performed at the University of Virginia Medical Center in Charlottesville, Virginia. UVA's Institutional Review Board approved (#18686) and supervised the study for subjects who were University of Virginia hospital patients and staff \> 18 years of age and who were able to give verbal consent.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age, who are able and willing to participate and have given verbal assent

Exclusion Criteria:

* Unable to give verbal assent
* \<18 years of age
* No or poor finger pulse, as determined through visual inspection for ischemic hands
A Technique Using EBL for Removal of Pedunculated Colon Polyps

Bleeding is the most common complication associated with polypectomy of large pedunculated colonic polyp. Although several techniques have been developed to minimize bleeding, none of these methods has become the gold standard. To prevent post-polypectomy bleeding effectively, the investigators developed and attempted a new endoscopic technique for removal of large long-stalked pedunculated colonic polyps using band ligations. This study aims to evaluate the safety and efficacy of a novel technique using endoscopic band ligation for removal of long-stalked pedunculated colon polyps.

A prospective single-center study was conducted. Targeted polyps were large (head size \>10 mm) with long stalk length (\>10 mm) in the distal colon. After finding target lesions by standard colonoscopy, conventional upper endoscopy with rubber band (endoscopic band ligation, EBL) was applied to squeeze the mid-portion of the stalk to form an omega shape, which had the dual effect of ligation and compression of feeding blood vessels. After strangulation of the stalk, snare polypectomy was performed at the stalk site just above the ligation. The investigators evaluated several parameters, including completeness of resection, procedure time, and complications, including immediate postpolypectomy bleeding, delayed postpolypectomy bleeding, and perforation.

Eligibility Criteria:
Inclusion Criteria:

* Polyps with head \>10 mm and stalk length \>10 mm;
* Location at the distal segments of the colon; and
* Benign features under endoscopic inspection (absence of ulceration and induration or friability).

Exclusion Criteria:

* Patients who refuse to sign the consent
Bone Health in Youth With Type 1 Diabetes

This is an observational study of children and young adults ages 6-20 years with type 1 diabetes and age- and race-matched controls. The investigators will be examining blood and urine hormone levels as well as measures of bone density including DXA and high-resolution peripheral quantitiative computed tomography. The investigators will also be collecting data regarding physical activity via use of wearable accelerometers. The investigators hypothesize that youth with type 1 diabetes will have slower bone accrual and impaired bone microarchitectural integrity compared with non-diabetic controls, and that bones of individuals with type 1 diabetes will not respond as well to physical activity. The investigators hypothesize that poor bone accrual will be associated with sub-optimal glucose control as well as lower levels of insulin-like growth factor 1.


Eligibility Criteria:
Inclusion Criteria:

* Age 6-20 years
* Out of honeymoon period (cohort with diabetes)

Exclusion Criteria:

* BMI\<5th percentile for age
* BMI\>95th percentile for age
* Celiac disease
* Hyperthyroidism, uncontrolled hypothyroidism
* History of significant hepatic disease, renal disease, oncologic disease, cardiovascular disease, psychiatric disease
* Anemia (Hgb \<11)
* Taking medications other than insulin known to affect bone health (including hormonal contraception, glucocorticoids, growth hormone)
Reduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt

The main objective of this work is to conduct a clinical trial in obese and non-obese individuals testing the ability of low-fat dairy yogurt to improve gastrointestinal health and reduce chronic inflammation. Our central hypothesis is that short and long-term consumption of low-fat dairy yogurt will reduce inflammation to a greater extent in obese individuals by improving intestinal barrier function.


Eligibility Criteria:
Inclusion Criteria:

* premenopausal women
* BMI from 18.5-27 and 30-40 kg/m2
* resting blood pressure \<140/90 mmHg
* not taking medication to control hypertension
* stable body weight for the previous 2 months
* willing to maintain a normal exercise level and avoid exercise 24 h prior to blood sampling
* willing to avoid yogurt and probiotic-containing foods or consume 2 servings of yogurt for the duration of the study

Exclusion Criteria:

* previous diagnoses of cardiovascular disease (CVD), diabetes, or arthritis (except for osteo-arthritis)
* currently being treated for cancer (i.e., chemotherapy, radiation therapy)
* prescribed estrogen replacement therapy
* practicing weight-loss, vegetarian, kosher, or vegan diets
* currently taking dietary supplements
* exceed alcohol consumption more than moderate drinking (1 drink/day or a total of 7/week)
* actively using antibiotics
* taking anti-inflammatory drugs
* have allergies to soy, egg or milk
* perimenopausal or menopausal symptoms
An Electronic Shared Decision-Making Application to Improve Asthma Outcomes

This study will increase knowledge about the feasibility and effect on patient satisfaction and clinical outcomes of using an electronic Shared Decision Making (SDM) application (app) for patients with asthma in the allergy/immunology clinic visit setting. SDM is defined as an approach where clinicians and patients share the best available evidence when faced with the task of making decisions, and where patients are supported to consider options and make informed choices.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Diagnosis of persistent asthma
* Have an in-person visit or telehealth encounter at the allergy/clinical immunology clinics participating in this study

Exclusion Criteria:

* Diagnosis of intermittent asthma
* Any other lung disease
* Smoking greater than 20 pack years or current smoking
* Mental impairment such that participation would not be possible
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-1944 in Healthy Adults

This is a Phase 1, FIH, single-center, randomized, placebo controlled, dose escalation study to evaluate the safety, tolerability, PK, and PD of mRNA-1944 in healthy adult subjects. Cohorts of mRNA-1944 are planned to be investigated in a sequential dose escalation manner.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 and ≤ 50 years of age
* Weight of 50 to 100 kg, inclusive
* In good general health as determined by medical history, clinical laboratory assessments, ECG results, vital sign measurements, and physical examination findings at screening
* Has access to consistent and reliable means of contact and agrees to stay in contact with the study site for the duration of the study

Exclusion Criteria:

* Any acute or chronic clinically significant disease, as determined by physical examination or laboratory screening tests
* Elevated liver function tests or safety laboratory test results
* Positive screening test for the presence of anti-CHIKV IgG
* Administration of another investigational study involving any investigational product within 60 days or 5 half-lives, whichever is longer
* Has received any live attenuated or inactive vaccines within 4 weeks prior to check-in, or plans to receive any vaccine during the study
* Known or suspected immune-mediated disease or immunosuppressive condition (including lymphoproliferative disorders)
* Any neurologic disorder
* History of idiopathic urticaria
* Any bleeding disorder that is considered a contraindication to study drug infusion or blood collection
* Receipt of immunoglobulins, a monoclonal antibody or any blood products within the preceding 6 months
* Any acute illness at the time of enrollment
* A positive test result for drugs of abuse
* A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2 antibodies
* A history of active cancer (malignancy) in the last 3 years
* Donation of ≥ 450 mL blood or blood products within 30 days of study drug infusion
Effect of Zinc Suplementation on Serum Hemosystein Level in Hemodialysis Patients

The purpose of this study is to study the effect of zinc supplementation in end stage renal failure on hemocystein level.

hemocystein increased in end stage renal failure and zinc involved in hemocystein metabolism thus zinc supplementation may be effective on hemocystein level.

Eligibility Criteria:
Inclusion Criteria:

* hemodialysis for 3 months
* older than 18 years old
* serum level of zinc less than 72.6 microgram/ l in men and less than 70 microgram/ l in female

Exclusion Criteria:

* acute renal failre
* malabsorption
* history of steroid or cytotoxic consumption
Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension

This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be masked; however only Stage 1 was conducted.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open angle glaucoma or ocular hypertension

Exclusion Criteria:

* Uncontrolled medical conditions
* Anticipated wearing of contact lenses during the study
Use of Dexmedetomidine in Acute Stroke and Cerebral Vasospasm Interventions

Dexmedetomidine is a unique sedative medication able to provide sedation without causing respiratory depression and maintaining neurological functions. Patients having an acute ischemic stroke and need to undergo endovascular therapy require constant assessment of their neurological status prior, during and after the interventional procedure. In this study the investigators will compare the efficacy of Dexmedetomidine to other standard sedative medications in providing optimal sedative effect while maintaining neurological function.

Precedex is a unique FDA-approved intravenous medication for conscious sedation in that it allows for "arousable" sedation, which is particularly appealing for use in patients with compromised neurologic function. While Precedex has been shown to be equivalent, if not superior to, conventional sedation in the procedural setting, it has not yet been evaluated in the setting of endovascular treatment of acute stroke. This setting is particularly ripe for evaluation, as there is currently controversy over the best method for management of patient sedation in light of the auxiliary need to preserve neurologic function. In order to evaluate the benefit of Precedex in this setting, it must be compared to the usual standard of care. Through the investigators double blinded randomized trial, the investigators will obtain information on the comparison between two arms, one receiving Precedex and the other the usual standard of care at the investigators institution, for achieving and maintaining a pre-defined level of conscious sedation, while preserving baseline neurologic status. This assessment will optimistically serve as the basis for future large-scale studies and ultimately to the establishment of Precedex as a first-line sedative in the management of acute stroke and cerebral vasospasm patients undergoing endovascular intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute ischemic stroke who require endovascular intervention with whom mNIHSS score can be obtained
* Patients with cerebral vasospasm suspiciousness with or without subarachnoid hemorrhage with whom mNIHSS score can be obtained.

Exclusion Criteria:

* History of severe hepatic disease or severe renal disease (GFR\<20).
* Hemodynamic instability.
* Pregnancy.
* Known allergy to study drug.
* Evidence or history of cardiac electrophysiology instability including uncontrolled hemodynamically unstable complex atrial/ventricular arrhythmia or conduction block at the time of evaluation with the exception of atrial fibrillation, and heart rate less than 60 or systolic blood pressure less than 90.
* Respiratory compromise requiring intubation.
* Any medical (including history of cardiac conduction block, major hepatic or renal disease) or laboratory abnormality that may increase the risk associated with the trial participation or drug administration or may interfere with interpretation of trial results.
Surfactant Disorders and Chronic Lung Disease

Interstitial lung diseases (ILD) in children represent a heterogeneous group of rare and not well defined disorders. Genetic abnormalities of surfactant proteins B (SFTPB) and more recently C (SFTPC) have been shown to be related to these pathologies. However, variability in the lung disease phenotype suggests the involvement of other surfactant-associated genes such as ABCA3 (ATP-binding cassette, sub-family A, member, 3). Thus, the aim of this project is: 1) to assess the prevalence of SFTPC mutation in children with chronic lung diseases, 2) to precise clinical and radiological features of children with SFTPC mutation, and 3) to identify environmental or genetic factors that may explain the extreme variability of this disease.

The first stage of this project will be to constitute a clinical, radiological, biological database of children (1 moth-17 years) with severe respiratory distress and/or an unexplained chronic ILD. Mutations in SFTPC, SFTPB and ABCA3 will be further identified by sequencing and documented with using the parents blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Children from 1 month to 17 years old with radiological alveola-interstitial syndrome and:
* Oxygen weaning failure \> 1 month in term newborn babies(\>37th week of PCA)or\> 40 weeks of PCA in preterm babies
* or
* Chronic respiratory disease define by chronic hypoxia and/or clinical signs of respiratory distress (cough, retractions, crackle)

Exclusion criteria:

* informed consent denied
* absence of social security
Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409

Primary Objective:

To evaluate long-term safety of alemtuzumab.

Secondary Objectives:

* To evaluate long term efficacy of alemtuzumab.
* To evaluate the safety profile of participants who received other Disease Modifying Treatment (DMT) following alemtuzumab treatment.
* To evaluate participant-reported Quality of Life (QoL) outcomes and health resource utilization of participant who received alemtuzumab.
* To evaluate as needed re-treatment with alemtuzumab and other DMTs.

The total duration per participants was up to 5.6 years.

As per Study Investigator discretion, participants can be treated with additional courses of alemtuzumab or any commercialized DMTs.

All participants who completed CAMMS03409 were allowed into the study, which might include specific vulnerable populations. If the investigator decided to treat a participant with a course of alemtuzumab, appropriate cautionary measures were applied as indicated in the approved labelling, or, in ex-European Union countries where Lemtrada was not approved, according to the investigator's brochure.

Eligibility Criteria:
Inclusion criteria:

Participant had completed at least 48 months of the Extension Study CAMMS03409. Signed written informed consent form.

Exclusion criteria:

Participant participating in another investigational interventional study.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study Evaluating Single Ascending Doses of MR1817

This is a first-in-human study of MR1817. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MR1817 after administration of ascending single oral doses to healthy adult subjects.


Eligibility Criteria:
Inclusion criteria: 1- Men or women of non-childbearing potential (WONCBP) aged 18 to 55 years inclusive at screening.

2- Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight ≥50 kg. 3- Healthy as determined by the investigator on the basis of screening evaluations.

Exclusion criteria: 1- Presence or history of any disorder that may prevent the successful completion of the study. 2- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. 3- History of drug abuse within 1 year before study day 1.
Investigation on the Effect of Smoking on the Expression of Pro- and Anti-thrombotic, Anti-oxidative, and Inflammatory Markers in Humans

Investigation on the effect of smoking on thrombus formation in humans. The expression of pro- and anti-thrombotic, anti-oxidative, and inflammatory markers will be assessed in 25-50 year old healthy smokers and non-smokers. The investigators are interested in possible differences between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Smoker
* Non-smokers

Exclusion Criteria:

* Disease
* Pregnancy
Circuitry Assessment and Reinforcement Training Effects on Recovery

This study investigates if electroencephalography (EEG) neurofeedback training is more beneficial than sham feedback training for the improvement of communication, anxiety, and sleep quality in individuals with aphasia. Half of the participants will receive active EEG neurofeedback sessions first, followed by sham feedback sessions in a crossover design. The other half of participants will undergo sham feedback sessions first, followed by active neurofeedback.

Neurofeedback, a form of biofeedback, provides a visual and/or audio representation of an individual's neural electrical activity from live EEG recording. Using operant conditioning principles, individuals are trained to increase or reduce patterns of brainwave activity to modify behavior and performance. Although neurofeedback has not yet been investigated as a treatment for aphasia or other communication deficits due to stroke or neurodegenerative disease, it may be effective. Previous studies have observed improvement in cognitive and behavioral measures in those with conditions such as Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder. Furthermore, it has been associated with reduced anxiety and sleep disruption, which both exacerbate language and communication impairments. Research is needed to determine if neurofeedback may be an effective treatment for language disorders such as PPA and post-stroke communication disorders.

It is possible that EEG neurofeedback, which focuses on improving abnormal brainwave patterns, could provide certain therapeutic benefits to individuals with PPA or post-stroke aphasia, either by directly affecting neural networks that underlie language, or more generally by reducing anxiety and inattention through behavioral conditioning. Reduction of anxiety in neurological diseases can be beneficial not only for functional performance but also sleep duration and quality.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PPA or aphasia secondary to stroke and presence of naming deficits with confirmation of diagnosis by neurologist
* Capable of giving informed consent or indicating another to provide informed consent
* Age 18 or older.
* If aphasia is secondary to stroke, the stroke must have occurred between 6 months and 5 years prior to enrollment in the study.

Exclusion Criteria:

* Lack of English proficiency
* Not medically stable
* Picture naming accuracy above 80% on the Philadelphia Naming Test (PNT)
* Prior history of neurologic disease affecting the brain (e.g., brain tumor, multiple sclerosis, traumatic brain injury) other than stroke or PPA and its underlying neurological pathologies: Alzheimer's Disease, Frontotemporal Lobar Degeneration or Dementia with Lewy bodies
* Prior history of severe psychiatric illness, developmental disorders or intellectual disability (e.g., PTSD, major depression, bipolar disorder, schizophrenia, obsessive compulsive disorder (OCD), autism spectrum disorders)
* Uncorrected severe visual loss or hearing loss by self-report and medical records