cyrilzakka/clinical-trials huggingface dataset:
Mathematical Modeling to Determine Basic Muscle Properties in the Failing Heart

According to the most recent information released by the American Heart Association, heart failure affects 5.8 million Americans and over 23 million people worldwide. In particular, diastolic heart failure (DHF) has emerged in approximately half of those suffering from heart disease and has become a major public health problem for many reasons, including the complexity of the disease, lack of effective drugs/therapies, requirement of invasive tests to diagnose and monitor DHF, and the absence of a suitable scientific model to study the disease. Scientists and physicians alike still do not fully understand what happens to the muscles in the heart (myocardium) patients who present with diastolic dysfunction or DHF. Therefore, the medical field is in need of an accurate model that can evaluate how diastolic dysfunction leads to heart failure and what happens at a cellular level as this disease emerges and progresses.

Our group has developed a mathematical model of the heart that gathers data from a procedure called an echocardiograph (echo) to analyze how muscles in the heart are functioning. This model incorporates how the heart muscle functions on a cellular level along with the overall functionality of the heart.

We hypothesize that this model will measure the specific properties of the heart muscle that affect their ability to contract and relax. This study will determine whether these properties will be different in patients with DHF compared to healthy controls. We also propose that these abnormalities in the heart muscle will correlate with the patient's degree of heart failure and their prognosis when doctors evaluate using standard clinical tests.

This study will be conducted at the University of Nebraska Medical Center (UNMC). 40 subjects will be enrolled, 20 healthy controls with no history of heart disease and 20 subjects who have been diagnosed with diastolic heart failure. Healthy controls will be required to undergo 1 echocardiograph procedure at UNMC. Subjects diagnosed with DHF will be required to undergo 6 echocardiograph procedure over the course of 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 19 years of age or older
* Control subjects must have no prior history or current signs of heart disease.
* Subjects with heart failure must meet one or more of the following criteria:
* Documented Diastolic Heart Failure, Grade II or greater (via NYHA functional class)
* Grade II or greater Diastolic Dysfunction by echocardiographic evaluation

Exclusion Criteria:

* Subjects under the age of 19 or unable to give consent will be excluded from this study.
* Greater than mild valvular disease
* Prior valve repair/replacement
Cohort of Patients With Rare Iron Overloads Excluding C282Y Homozygosity

The study explores the hepcidin deficiency causes of rare iron overload (excluding C282Y homozygosity), and aim to characterize this iron overload in term of clinical, biological, genetic and functional spacificities.

Chronic iron overload are responsible for morbidity and mortality. There are many causes, genetic and acquired. Hepcidin deficiency related to genetic desease is one of them.

This study concerns specifically this cause, and seeks to characterize these iron overloads on clinical, biological, genetic and functional point of view.

A significant number of patients with chronic iron overload, present a phenotype of hepcidin deficiency. This profile is characterized by an elevated plasma iron increased serum transferrin saturation, a transferrin saturation, and a parenchyma distribution of iron overload. These diseases either remains unexplained or are associated with mutations in the gene involved in iron metablism regulation.

The main objective of this study is to characterize these iron overloads with phenotype of hepcidin deficiency not related to homozygosity C282Y (clinical, biological and genetic).

Eligibility Criteria:
Inclusion Criteria:

* Biological profile suggestive of hepcidin deficiency:

  * increase of transferrin saturation coefficient (\> 50 %) verified on at least 2 times, and calculated from the transferrinemia.
  * Proved hepatic iron overload: by the dosage of the iron hepatic concentration either on block hepatic biopsic, or by MRI according to the method of quantification of the iron validated overload (by adopting a threshold of 100 µmol /g)
  * Patient's written consent for examination of genetic characteristics for diagnosis and collection development for genetic and not genetic research within the framework of an abnormality of the iron metabolism
  * Patient written inform consent.

Exclusion Criteria:

* HFE hemochromatosis: homozygosity C282Y/C282Y
* Treatment with iterative phlebotomy
* Hematologic diseases with dyserythropoiesis and/or repeated transfusions
* Haptoglobin low, below normal directing towards the diagnosis of chronic hemolysis, myelodysplasia
* Prolonged oral or parenteral iron supplementation
* Current or past excessive regular drinking
* Patient minor or under legal protection measure
A Study of Mosliciguat in PH-ILD

This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

This study is a randomized, double-blind, placebo-controlled study with an extension.

The study consists of 2 periods: a blinded placebo-controlled period (24 weeks) and an extension (beyond 24 weeks).

Participants will be randomized to receive mosliciguat or placebo in the 24-week double-blind treatment period.

All participants who complete the 24-week double-blind period may continue to participate in the extension period where all participants will receive mosliciguat.

Eligibility Criteria:
Inclusion Criteria:

* Participants willing and able to provide informed consent
* Participants with diagnosis of Interstitial Lung Disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed diseases include:

  1. Idiopathic interstitial pneumonia (IIP)
  2. Chronic hypersensitivity pneumonitis
  3. ILD associated with connective tissue disease (CTD) with a forced vital capacity (FVC) \< 70% of predicted
* Confirmed pulmonary hypertension (PH) by right heart catheterization (RHC).
* Ability to perform 6MWD ≥100 meters.

Exclusion Criteria:

* Diagnosis of PH Group 1 (eg. pulmonary arterial hypertension), Group 2 (related to left-heart dysfunction), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified).
* Exacerbation of underlying lung disease within 28 days prior to randomization.
* Initiation of pulmonary rehabilitation within 28 days prior to randomization.
* Receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
* History or intolerance to or lack of efficacy with mosliciguat or sGC stimulators or activators.
* Receipt of investigational, or experimental therapy within 42 days OR 5 half-lives prior to randomization.

Note: Other inclusion and exclusion criteria may apply.
Phase II Study to Assess RG2417 in the Treatment of Bipolar I Depression

The primary purpose of this study is to determine the safety and efficacy of oral RG2417 (Uridine) when administered to patients with Bipolar I depression twice daily for six weeks.


Eligibility Criteria:
Inclusion Criteria:

1. DSM-IV-TR diagnosis of Bipolar I Depression
2. 18 to 65 years of age, inclusive
3. Depressive phase, as measured by MADRS greater than or equal to 20 at Screening and Day1
4. Duration of current depressive episode of at least four weeks by Day 1
5. Competent to give informed consent

Exclusion Criteria:

1. Manic/hypomanic/mixed episode as determined by the MINI at Screening and/or a Young Mania Rating Scale (YMRS) score of \> 12 at Screening and/or Day 1
2. Dementia or any current Axis I diagnosis (excluding bipolar I) requiring pharmacological treatments
3. A history of alcohol or substance dependence within six months of Day 1, or a history of alcohol or substance abuse within three months of Day 1
4. Urine drug screen positive for amphetamines, cocaine metabolites, opiates and/or phencyclindine (PCP)
5. An Axis II diagnosis that is likely to interfere with protocol compliance
6. Initiation of or increase in psychotherapy within 4 weeks of Screening
7. Psychotropic medication (excluding fluoxetine) within 24 hours of initiation of study drug on Day 1; fluoxetine within 2 weeks of initiation of study drug on Day 1
8. Serious suicidal or homicidal risk as determined by the investigator and/or a score of \> 5 on the suicide item #10 of the MADRS at Screening and/or Day 1
9. History of sensitivity to any of the ingredients in the study drug
10. Clinically significant abnormality in any screening laboratory results
11. Clinically significant organic disease, including cardiovascular, endocrine, hepatic, pulmonary, neurologic, or renal disease, or any other medical condition, serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would interfere with the performance or interpretability of, or put the patient at risk from, the study procedures
12. Women who are pregnant, breastfeeding, or refuse to use adequate birth control
13. Current seizure disorder
14. Participation in an investigational drug study within twenty-eight days of Day 1
15. Current psychotic episode
16. Clozaril use and/or electroconvulsive therapy within six months of Day 1
17. Failure of three or more adequate trials of standard therapies for depression during the current episode
18. Current episode of depression is longer than one year
Digital Single-operator Cholangioscopy and Intraductal Ultrasound for Nonicteric Biliary Strictures

This study aims to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of indeterminate biliary stricture.

Although early and accurate diagnosis of cholangiocarcinoma from the biliary stricture is important, accurate differential diagnosis is still difficult even in computed tomography and magnetic resonance imaging. We planned to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of biliary stricture.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 19 to under 80
2. Presence of nonicteric biliary stricture
3. Previous endoscopic sphincterotomy or papillary balloon dilatation

Exclusion Criteria:

1. Bleeding tendency (INR \&gt; 1.5 or platelets \&lt; 50000 mm3)
2. Contraindication to ERCP
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder

The purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder. The investigational drug will be given as additional treatment with either lithium or valproate, which are already FDA (Food and Drug Administration)-approved treatments for mania.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bipolar disorder (type I) with manic or mixed episodes (including patients with/without psychotic features or with/without a history of rapid cycling)
* In need of psychiatric treatment
* Cooperation and willingness to complete all aspects of the study

Exclusion Criteria:

* Current diagnosis other than bipolar I disorder
* History of schizophrenia or schizoaffective disorder
* Drug dependence within 1 month prior to study start or testing positive in a urine drug test
* Suicide attempt within 1 month prior to study start or at immediate risk of harm to self or others
* Any form of psychotherapy within 1 month prior to study start
Predictors of Upper Airway Function and Sleep-disordered Breathing in the Critically Ill

This is part 2 of the #NCT01618240 under the same IRB protocol #2010P001919. The primary objective of this study is to examine factors that are related to sleep-disordered breathing and upper airway patency in critically ill patients who have been recently mechanically ventilated. Our primary hypothesize is that sedatives and neuromuscular blocking agents given in the ICU prior to extubation and during the first night following extubation are associated with sleep-disordered breathing. The secondary hypotheses are that duration of mechanical ventilation, BMI, and muscle strength are associated with sleep-disordered breathing during the night after extubation.

The secondary objective is to evaluate if sleep-disordered breathing in the ICU can be predicted by standard pulmonary function testing in the ICU.


Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted to the SICU
2. Age over 18 years.
3. Ventilated patients with an endotracheal tube for at least 24 hours.

Exclusion Criteria:

1. Decreased level of consciousness as defined by a Richmond Agitation Sedation Scale (RASS) of 0.
2. Non-cooperative patient, CAM score positive for risk of delirium.
3. For women: pregnancy.
Evaluation of Hydroxychloroquine to Prevent CIPN

The study is being done to research if hydroxychloroquine can prevent chemotherapy induced peripheral neuropathy. Certain chemotherapy drugs, like paclitaxel, are known to cause neuropathy which can impact quality of life. Currently, there are no options for preventing peripheral neuropathy. In addition, there are no useful methods to assess peripheral nerve damage. This study will also explore using a study MRI of patients' feet prior to starting chemotherapy and after they have completed chemotherapy to see if there is any difference in their nerve structure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stage 1-3 breast cancer or gynecological cancer treated with curative intent
* Age ≥ 21 years old
* No prior neurotoxic chemotherapies
* No other neurotoxic chemotherapies planned during paclitaxel treatment (i.e, platinum)
* Need to be treated with paclitaxel weekly x 12 doses as determined by their treating physician
* Be able to undergo MR Imaging
* Be willing to comply with scheduled visits, treatment plan, and MR imaging
* Adequate organ function as defined as:

Hematologic:

Absolute neutrophil count (ANC) ≥ 1500/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 9 g/dL

Hepatic:

Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN

Renal:

Estimated creatinine clearance (CrCl)≥ 50 mL/min by Cockcroft-Gault formula

Exclusion Criteria:

* Stage IV cancer
* CTCAE neurological function \> grade 1 at baseline
* Mental limitation that precludes understanding of or completion of questionnaires
* History of diabetes or other neurological disorders
* Preexisting peripheral neuropathy
* Prior exposure to neurotoxic chemotherapy
* Currently taking medication to treat or prevent neuropathy
* Have non-MRI compatible metallic objects on/in body
* Have metallic hardware in the lower extremity which is MR compatible however would create too much artifact for MR examination
* Pregnant or lactating patients. Women of childbearing potential and sexually active men must use an effective contraception method during rreatment and for three months after completing treatment. Patients of childbearing potential must have a negative serum or urine B-hCG pregnancy test at screening.
* History or current evidence of central serous retinopathy (CSR) or retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity) or macular degeneration.
* QTc prolongation defined as a QTcF \> 500 ms
* Known glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
Non-Invasive Determination of Cardiac Output by Inertgas Rebreathing Method

The cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac diseases. The current standard methods for the determination of the CO, however, are either invasive (e.g. right heart catheterization) or technically expendable and expensive (magnetic resonance tomography, MRT). The traditional non-invasive methods of determining the CO by rebreathing of carbon dioxide are easily carried out but suffer from methodical inaccuracies. Therefore the aim of the study at hand was to evaluate a new method for determining the CO by means of the inert gas rebreathing method.


Eligibility Criteria:
Inclusion Criteria:

* Indication for CMR
* Ability of following instructions for rebreathing test
Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis

Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.


Eligibility Criteria:
Inclusion Criteria:

* previous diagnosis of ulcerative colitis confirmed by histology that has been considered to be in remission for =\> 30 days
* female subjects must be post-menopausal, surgically or biologically sterile, or with a negative urine pregnancy test at screening and on adequate contraception

Exclusion Criteria:

* proctitis
* previous resective colonic surgery
* Crohn's disease
* hypersensitivity to salicylates
* moderate/severe renal impairment
Congenital Heart Defects and NIRS

Congenital Heart Defects and NIRS

Brain, kidney and intestinal tissue oxygenation in newborns with congenital heart defects assessed by near-infrared spectroscopy.

Eligibility Criteria:
Inclusion Criteria:

Investigators included term newborns with critical structural CHD (of different types) who required surgical or transcatheter procedure in the first year of life. CHD were diagnosed by pediatric cardiologist by clinical examination and echocardiography.

Exclusion Criteria:

The exclusion criteria were pulmonary or neurological disease, perinatal asphyxia, acute illness, prematurity and congenital abnormality other than CHD.
The Effects of a Digital Application for GDM Management in Improving Patients' Compliance

Gestational diabetes mellitus (GDM) is the most prevalent complication in pregnancy. Patients' follow-up and treatment is performed in specialized GDM clinics that teach and support women in implementing lifestyle changes, blood glucose self-monitoring, and nutritional and pharmacologic therapy.

Recently, mobile health (mHealth) applications have been introduced as a resource to improve self-management and follow-up among pregnant women. The proposed study will examine the efficacy of the GDM management mHealth application in improving patients' compliance and satisfaction, glycemic control, and pregnancy outcomes.

A multicenter randomized controlled trial of women with GDM treated in the GDM clinics. Women will be randomly allocated to a research group that will use the GDM application and a control group that will receive regular follow-up without the GDM application. The primary outcome is patient compliance, defined as the actual blood glucose measurements/instructed measurements ×100. Secondary outcomes include glycemic control parameters, and maternal and neonatal complications.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women diagnosed with GDM from 13.0 gestational week
* Recruitment until 34.0 gestational week
* 18 years old and older
* Singleton pregnancy

Exclusion Criteria:

* Women with pre-gestational diabetes mellitus
* Multiple pregnancy
* Women without a Smartphone that can support the GDM application
* Refusal to participate
Examination of Valve Insufficiency Before and After MitraClip or TAVI Procedure by 3D Echocardiography Compared to MRI

Aim of the study is the definition of criteria for a standardized assessment of heart function by 3D echocardiographic procedures. Standardized criteria will be defined to assess aortic valve insufficiency after TAVI and success of mitral valve replacement respectively.

Echocardiography: GE Healthcare Vivid E9

Eligibility Criteria:
Inclusion Criteria:

* patients with severe symptoms of an aortic stenosis who underwent catheter based implantation of an aortic valve
* patients who are planned to undergo a reconstruction of the mitral valve with the MitraClip System
* Patients who are aged above 18 years and legally competent
* signed informed consent

Exclusion Criteria:

* patients with previous myocard infarction, previous heart surgeries, malignity or valvular abnormities \> stage 1
* patients with atrial fibrillation
* pregnant and breast-feeding women
* patients with disturbed central nerve system
* patients with pacemaker, implants, ferrous clamps,insulin pump
* patients with tattoo
* patients with claustrophobia
* patiens with asthma
Study of Innovative Drug Treatment Therapy for Pediatric Mitral Regurgitation

The goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric patients with mild to moderate mitral valve regurgitation.

The main questions it aims to answer are:

* Can a modified drug therapy improve both left ventricular and mitral valve function in pediatric patients with mild to moderate mitral valve regurgitation?
* Can the adverse drug reactions caused by the modified drug therapy be non-inferior (clinically acceptable) to those of the traditional drug therapy? Participants will be assigned to either the Modified Drug Therapy Group (comprising angiotensin-converting enzyme inhibitor (ACE-I), beta-blockers, diuretics, potassium supplements, and spironolactone) or the Traditional Drug Therapy Group (diuretics and potassium supplements) based on personal preferences and clinical assessments by their attending physicians. They will undergo a one-year course of medication. Additionally, echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted before the initiation of medication therapy and at 3 months, 6 months, and 12 months after treatment commencement.

Researchers will compare the Modified Drug Therapy Group and the Traditional Drug Therapy Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 12 months of treatment, is lower in the former than in the latter.


Eligibility Criteria:
Inclusion Criteria:

* \< 14 years old
* had not undertake mitral valve surgery before
* moderate to severe mitral regurgitation

Exclusion Criteria:

* moderate to severe mitral regurgitation which concommitant with other cardiac malformation which can not be correct or can only perform palliative surgery
* concommitant with mitral stenosis
* ischemic mitral regurgitation (for example, concommitant with anomalous origin of coronary artery)
* Barlow syndrome
* dysplasia of mitral leaflet
* complete/Partial endocardial cushion defect
* common atrioventricular valve
* atrioventricular common channel
* cardiomyopathy
* other mitral valve surgery contraindications
* moderate to severe mitral regurgitation requires mitral valve surgery