cyrilzakka/clinical-trials huggingface dataset:
Closed-Loop Glucagon Administration For Hypoglycemia Treatment

This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers glucagon only can prevent or treat hypoglycemia vs. usual care for people with type 1 diabetes \> 21 years old.


Eligibility Criteria:
Inclusion Criteria:

* Age 21 years or older with type 1 diabetes for at least one year.
* Otherwise healthy (mild chronic disease such as asthma, hypertension, and depression will be allowed if well controlled).
* Self-reported frequency of documented hypoglycemia (BG \< 60 mg/dl) of at least 2 times per week
* Partial hypoglycemic unawareness (inconsistent symptoms with BG \< 50 mg/dl) or hypoglycemic unawareness (minimal or no symptoms with BG \< 50 mg/dl)

Exclusion Criteria:

* Unable to provide informed consent.
* Unable to comply with study procedures.
* Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature.
* Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception
* History of cystic fibrosis, pancreatitis, or other pancreatic disease other than type 1 diabetes
* End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
* Any known liver or biliary disease including cirrhosis, alcoholic liver disease, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, any form of viral hepatitis.
* Congestive heart failure (established history of CHF, paroxysmal nocturnal dyspnea, or orthopnea).
* Acute illness or exacerbation of chronic illness at the time of the study.
* Seizure disorder or history of hypoglycemic seizure in the last 1 year
* History of pheochromocytoma. Fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor:
* Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year).
* Current alcohol abuse (intake averaging \> 3 drinks daily in last 30 days) or substance abuse (any use within the last 6 months of controlled substances without a prescription).
* Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference.
* History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
* Unwilling or unable to completely avoid acetaminophen during the study period.
* Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures.
Effect of Intravenous Acetadote on Incidence of Contrast Induced Nephropathy

In patients undergoing coronary angiography, the incidence of contrast induced nephropathy(CIN)varies widely and ranges from \< 5% in the lowest risk patients, to nearly 50% in the highest risk patients. Prior data has shown oral n-acetyl cysteine (NAC) to be effective in reducing the incidence of CIN.Due to extensive first pass metabolism, the bioavailability of oral NAC is poor and ranges from 4%-10%. We hypothesize that the incidence of CIN will be reduced in patients with ACS who undergo PCI by the prophylactic administration of intravenous NAC.

This is a prospective, randomized, double-blind, placebo-controlled single center clinical trial designed to evaluate the effects of intravenous NAC on patients with acute coronary syndromes (ACS)undergoing coronary angiography and/or percutaneous coronary intervention (PCI). The medication Acetadote is provided by Cumberland Pharmaceuticals Inc (www.cumberlandpharma.com).

Patients will be excluded if they have end-stage renal disease requiring dialysis,known hypersensitivity to NAC or a history of life-threatening contrast reaction. Primary end-point is incidence of CIN. Secondary end-points are in-hospital mortality,30-day mortality,duration of hospitalization and change in serum cystatin C level.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older.
2. Hospitalized with a primary diagnosis of acute coronary syndrome.
3. Scheduled for coronary angiography or intervention during the current hospitalization.

Exclusion Criteria:

1. Have end-stage renal disease (ESRD) requiring dialysis.
2. Have a known hypersensitivity to NAC.
3. Have a history of life-threatening contrast reaction. -
Hereditary Hepatorenal Tyrosinemia Natural History in Egypt and the Arab World (Multicenter Clinical Study)

The purpose of the registry/repository is to understand the natural history of tyrosinemia in our region and to provide a mechanism to store data and specimens to support the conduct of future research about hereditary tyrosinemia among the Arabs.

The purpose of this study is to create an electronic registry of phenotypic, laboratory information, treatment and outcomes options for tyrosinemia type I. The registry is longitudinal in nature including retrospective clinical data from birth to the most recent encounter with all data entered in chronological fashion. The goals of this registry are the better understanding of the natural history and treatment outcomes of these patients and to determine/evaluate biochemical and clinical parameters for monitoring and prognosis of tyrosinemia type I.

Eligibility Criteria:
Inclusion Criteria:

1. Biochemical or molecular diagnosis of Tyrosinemia Type I.
2. Examined/followed by one of the participating sites.
3. Parental/guardian permission (informed consent) for participation.

Exclusion Criteria:

1. Diagnosis of tyrosinemia has been excluded.
2. Not examined/followed by one of the participating sites.
3. Unwilling to provide informed consent for participation.
Kinetics of C-Reactive Protein During the Management of Acute Coronary Syndrome Treated by Transluminal Angioplasty

The primary objective of the study focuses on the kinetics of plasma CRP measured during the overall management (before the angioplasty procedure until the discharge of hospitalization) of patients with ST+ ACS requiring emergency transluminal angioplasty.

During the management of acute coronary syndrome with ST segment elevation (ACS-ST+), an ischemia-reperfusion syndrome is observed in connection with primary coronary occlusion (ischemia) and percutaneous angioplasty during the therapeutic coronary reperfusion.

This ischemia-reperfusion syndrome results biologically in an inflammatory syndrome evaluated in particular by the assay of C-reactive protein (CRP). CRP is a marker of inflammation used in routine practice. Previous studies have reported the prognostic value of CRP at the 48th hour of hospital treatment for ST+ ACS. If the value of CRP is correlated with the risk of mortality and heart failure, the fact remains that no study has, to date, studied its kinetics during the overall management (pre and intra-hospital) of ACS ST+. This is all the more important since the previous therapies taken by the patient (statins for example) and/or those administered during treatment (colchicine, ticagrelor, anti-GPIIbIIIa are capable of modifying the pre-hospital value of the CRP.

In this study, the kinetics of plasma CRP measured during the first medical contact (emergency, cardiology or resuscitation), then, in the catheterization room before the angioplasty procedure, then in the catheterization room, after the angioplasty, then at the 6th hour (H6), at the 12th hour (H12), at the 24th hour (H24), at the 48th hour (H48) and once a week until the 7th day then once a week until discharge hospitalization with a maximum of 30 days of follow-up, as part of the usual follow-up of patients with ST+ ACS requiring emergency transluminal angioplasty.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old;
* ST+ ACS requiring emergency transluminal angioplasty;
* Affiliation to a social security scheme or beneficiary.

Exclusion Criteria:

* ST+ ACS not requiring emergency transluminal angioplasty;
* Pregnancy;
* Under guardianship or curatorship;
* Foreign patient under french AME scheme.
Reproducibility Study of Transcranial Doppler

Hardening of the neck vessels (carotid arteries) caused by fatty deposits called 'plaques' is a common cause of strokes. Over time plaques can burst or may lead to a severe narrowing (stenosis) of the neck artery. When plaques burst, small clots or fatty particles (called microemboli) break off, block brain vessels and lead to a stroke. Researchers have an incomplete understanding of the processes that cause hardening of the arteries, development of small clots and are unable to predict who will have a stroke. At present, the only ultrasound scan that evaluates circulation in the head and detects these small clots is called the Transcranial Doppler ultrasound. The aim of the study is to test this simple ultrasound technique to see if it can detect signals that may correspond to these small clots or fatty particles. The other objective is to see how repeatable the ultrasound technique is. This may help to identify patients with hardened neck arteries who are at higher risk of a recurrent stroke. This could also potentially improve patients selection to a targeted surgical or future novel pharmacological therapy.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with no previous history of cerebrovascular disease and aged over 18 years old.
* Patients with symptomatic cerebrovascular event (stroke, transient ischaemic attack or amaurosis fugax) and image confirmed carotid artery stenosis of \>30%. This will include patients scheduled for carotid endarterectomy (\>50% for men and \>70% for women, by North American Symptomatic Carotid Endarterectomy Trial criteria) or treated conservatively with an optimal medical therapy (if patient declined surgical intervention or is outside surgical criteria for carotid endarterectomy).

Exclusion Criteria:

* Subjects unable to comply with the study procedures such as a severe disabling stroke.
* Inadequate temporal window for Transcranial Doppler assessment.
* Adults with incapacity.
Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage

Cerebral vasospasm(CVS) after subarachnoid hemorrhage (SAH) results in a considerable amount of transient or even permanent neurological deficits and poor outcome of the patients. Transluminal Balloon angioplasty (TBA) or intraarterial application of vasodilators represents a rescue therapy for severe CVS. Indication, duration and efficacy of this treatment, however, is still under debate. Aim of the study is to investigate if such a rescue treatment can significantly reduce new delayed ischemic cerebral deficits after SAH. Hypothesis is that the occurance of delayed infarcts can be reduced by repetetive intraarterial therapy to more than 50 %.


Eligibility Criteria:
Inclusion Criteria:

* SAH (WFNS 1-4)
* Perfusion relevant CVS
* Ability for MRI, DSA and intraarterial treatment

Exclusion Criteria:

* extended cerebral infarcts
* SAH or ICH from AVM or flow associated aneurysm
* Non aneurismal SAH
* Relevant non spastic stenosis of brain supplying arteries
Genetics of Latent Autoimmune Diabetes in Adults

This is a prospective study that will study adults and has the objective of examining 'Latent Autoimmune Diabetes in Adults' (LADA) to understand how this trait is influenced by genetic factors.

A case-control study approach will be used to compare the allelic frequencies of Deoxyribonucleic acid (DNA) markers of the cases (i.e., LADA patients) to a randomly selected control samples that does not have the trait under study. To study the role of genetic factors in LADA, the study seeks to determine if certain genomic regions that are captured or mirrored by selective Single nucleotide polymorphisms (SNPs) that are genotyped, are over or underrepresented in those with the disease compared to those who do not. The level of auto-antibodies is the serum can also be studied as a quantitative trait where we ask the question if there is correlation with specific SNP alleles that are genotyped. The markers that are found to be over or under-represented in the study cases will then be tested in an independent set of patients also recruited in this study. This allows us to filter markers that show significance simply by chance and prevents us from being misled.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed type 2 Diabetes (T2D) patient with: BMI \<30 at diagnosis; Age \>25-\<50 at diagnosis

OR

* Diagnosed type 1 Diabetes (T1D) patient with: Age \>25 at diagnosis

OR

- Currently Diagnosed with LADA with age at initial diagnosis of Diabetes \>25 years and a positive GAD65 antibody test

Exclusion Criteria:

* Any underlying disease or condition that is a contraindication for obtaining 18.0 ml of blood.
* Inability to obtain an informed consent from a given LADA case.
* Blood sampling has already occurred for a given subject.
* Previous GAD65 antibody test(s) negative.
Effects of Alcoholic Beverages in Pro-inflammatory and Antioxidant Profile After an Oral Fat Diet

Hypothesis: Red wine intake but not other alcoholic beverages together with a fat diet will decrease inflammatory factors and lipid peroxidation and decrease antioxidant capacity in healthy people after a five days period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Individuals with a plasma cholesterol level \> 220 mg/dl
* Smokers
Comparing Imitation and Stereotyped Behaviors in Autistic Children: Robots vs. Human Operators

Virtual QT is a social robot designed to interact with humans in social and educational contexts. Equipped with visual and vocal interfaces, the robot can recognize and respond to various human inputs, providing emotional support and social interaction.

It uses facial expressions, gestures, and movements to communicate, encouraging engagement and supporting learning through playful and educational activities. Its ergonomic design and interactive approach make it suitable for both clinical and educational settings.

The aim of this study is to examine the effectiveness of the QTrobot in interventions for children with Autism Spectrum Disorder (ASD) and to assess whether children's attention and imitation are equally effective with the QTrobot compared to interacting with a human being.

Furthermore, the presence of significant differences between motor and expressive imitation, when interacting with the robot as opposed to a human interlocutor, will be investigated. A key aspect of this investigation is to assess whether the presence of the QTrobot can positively influence the repetitive or stereotyped behaviors exhibited by the children, compared to interaction with a person. Additionally, to further understanding, the children's heart rate will be monitored through the use of a sensor that will allow to evaluate how heart rate affects performance outcomes during interaction with the QTrobot and with a human being.

In this study, children will be recruited to take part in two separate sessions, both involving the same task. During the first session, the task will be carried out between the child and the human operator. Subsequently, in the same task, the child will interact with the QT robot. Throughout both task administrations, the child will wear a sensor to detect their heart rate. Furthermore, all task sessions will be video-recorded to conduct subsequent video analysis and make notes on imitation behaviors and stereotypical actions relevant to the study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Autism
* QI ≥ 75

Exclusion Criteria:

* Motor deficits due to another clinical condition
Optimal Strategy for the Management of ASCUS Cytology in Health Care Services of Medellin, Colombia

Cervical cancer as well cervical preneoplastic abnormalities (CIN2+) are cause by human papillomavirus (HPV) infection. These abnormalities have been historically detected by cervical cytology, but recent evidence shows that HPV testing is superior to cytology to detect cervical lesions that eventually will progress to cancer. Despite evidence, conventional cytology (Pap) remains as a primary screening test in Colombia and HPV test is recommended as a triage test for women with atypical squamous cells of undetermined significance (ASC-US) in settings around the world. Women with ASC-US have low risk to CIN2+ but higher than healthy population, and therefore it is important to provide appropriate clinical management. However, there is no consensus of how to deal women with ASC-US and therefore there are still three strategies for this purpose: 1) immediate colposcopy, 2) repeat conventional cytology at 6 and 12 months and 3) HPV testing. The main objective of this study is to compare the effectiveness and the efficient among the strategies as well as to evaluate the acceptability of the HPV testing in a real-life setting.

The aim of this study is to compare the effectiveness and efficiency of immediate colposcopy (IC), repeat conventional cytology at 6 and 12 months (RC) and HPV triage (HPV) (QIAGEN-The digene HPV Test®) for the clinical management of women with ASC-US insured in healthcare management organizations (HMO) within the Colombian health security system. This study randomized 2,661 20-69 years old women with ASC-US, insured in HMOs in Medellin-Colombia to 3 arms: IC, RC and HPV. All women are scheduled for a visit at 2 years after recruitment that includes HPV-test/cytology and colposcopy either if HPV+ (RLU\>=1) or abnormal cytology (\>=ASC-US). This colposcopy is performed by a trained colposcopist and women are followed-up according to a well-defined algorithm. The fewer high-grade cervical neoplasia (CIN2+) rate at the end of following will determine the most effective arm. The most efficiency arm will be which reach the major effective with the minimum resource (cytologies, colposcopies and histologies) consumed. The resource consumed is being retrieved from the HMOs. This study also pretends to evaluate the acceptability of the HPV testing. This study will allow us to know if within the Colombian health security system, the HPV test will remain superior to repeating cytology and/or to immediate colposcopy as it has been demonstrated in randomized controlled trials carried out in outside settings.

Eligibility Criteria:
Inclusion Criteria:

* ASC-US cytology, living in metropolitan area of Medellin

Exclusion Criteria:

* Previous abnormal cytology
Effects of Dynamic Taping on Shoulder Isokinetics Strength and Muscle Fatigue.

Maintaining shoulder stability requires good neuromuscular control. Imbalances in shoulder internal and external rotator strength may increase the risk of shoulder injuries in overhead athletes, and the compromised fatigue resistance of the external rotators may worsen this imbalance during sports activities. Additionally, poor scapular neuromuscular control is associated with shoulder problems, such as shoulder impingement syndrome. Previous research has shown that individuals with shoulder impingement syndrome exhibit poor scapular motion control and altered corticomotor control. Poor scapular motion control, pain, functional impairment, and changes in corticomotor control interact to form a vicious cycle. Various treatments have been attempted to improve neuromuscular control, including taping. Most past studies have focused on the efficacy of rigid tape and kinesio tape, while dynamic tape has gained popularity in recent years. Due to its material properties, dynamic tape is theoretically able to absorb loads, provide force, and correct movements. However, there is currently a lack of evidence supporting the effectiveness of dynamic tape. No research has yet explored whether dynamic tape can provide force to increase muscle strength and reduce fatigue or whether its movement correction functions can improve neuromuscular control and corticomotor control. Therefore, this project plans to conduct an experiment to investigate the effects of dynamic tape on external rotator strength and fatigue in recreational overhead athletes, as well as its impact on neuromuscular control and corticomotor excitability in recreational overhead athletes with shoulder impingement syndrome. In the experiment, 37 healthy recreational overhead athletes will participate in three testing sessions spaced one week apart, receiving kinesio tape, dynamic tape, and sham tape. After taping, they will perform fatigue-inducing activities. Isokinetic strength of internal and external rotators will be measured before taping, after taping, and after fatigue-inducing activities to observe the effects of dynamic tape on muscle strength and fatigue compared to kinesio tape and sham tape.


Eligibility Criteria:
Inclusion Criteria:

* practice overhead exercise more than six hours a week
* aged 18 to 40 years old

Exclusion Criteria:

* have a history of dislocation, fracture, or surgery of neck or upper extremity
* a history of pain or injuries over the neck or upper extremities within the past 12 months
* brain injury and neurological impairment
* arm elevation angle is less than 150 degrees
A Study of DS-1211b in Individuals With PseudoXanthoma Elasticum

This study was designed to evaluate the safety, tolerability, pharmacodynamics (PD) of DS-1211b, and pharmacokinetics (PK) in individuals with Pseudoxanthoma elasticum (PXE). PXE is a rare disease that is associated with significant risks of visual impairments and comorbidity from peripheral and cardiovascular diseases, and adversely impacts the quality of life in afflicted individuals.

DS-1211b, a potent small-molecule inhibitor of tissue-nonspecific alkaline phosphatase, is being developed for the treatment ectopic calcification diseases such as PXE. This study will assess DS-1211b (low-, middle-, and high-dose tablets) administered once daily for 12 weeks in individuals with PXE.

Eligibility Criteria:
Key Inclusion Criteria:

* Signed and dated informed consent
* Male or female participants aged 18 to 75 years at screening
* Have an established diagnosis of PXE
* Fully vaccinated for coronavirus disease 2019 (COVID-19) per current Center for Disease Control and Prevention guidelines

Key Exclusion Criteria:

* Have a history of bone fracture in the past 6 months
* Have a history of active metabolic bone disease, excluding osteopenia or osteoporosis without fragility fracture
* Have a history of calcium pyrophosphate deposit disease
* Have a history of hypophosphatasia
* Have a history of untreated hyperparathyroidism
* Participated in another interventional research study in the past 60 days.
* Used bisphosphonate in the preceding 12 months or had plans to use bisphosphonate during the study.
* Received Vitamin B6 supplementation \>5 mg/day in the month prior to screening and during the study
* Initiated or changed dose of Vitamin D in the preceding month prior to screening
* Have an alkaline phosphatase \<lower limit of normal (LLN) range
* Have a QTcF interval duration \>450 ms at screening
* Have moderate to severe renal insufficiency
* Are pregnant or breast-feeding women
* Are female participants unwilling to use contraceptive methods
* Have any elective surgery planned during the study period
* Have any other significant condition (medical, psychiatric, social, or medication) that, in the judgment of the Investigator, would prevent full participation or would be inappropriate for the study