cyrilzakka/clinical-trials huggingface dataset:
Heart Map Study -Determination of Myocardial Relaxation Times Values in Healthy Volunters

T1, T2 and T2\* relaxation times, as determined with cardiac MRI, are markers of myocardial tissue content (water, fibrosis, iron).

The aim of study is to determine the normal values of T1, T2 and T2\* relaxation times in healthy volunters aged 18-69 years using 1.5T clinical MRI.

Cardiac MRI is more and more used in patients with ischaemic and non-ischaemic heart diseases. One major strength of MRI is its great potential for tissue characterization.

For early detection and follow-up of patients with hemosiderosis, who are at high risk of myocardial iron overload, cardiac MRI seems to be the most reliable, more reproducible and less invasive method. In addition MRI does not require injection of contrast media. It is commonly accepted that myocardial T2 \* value of less than 20 ms corresponds to iron overload in the myocardium. However, this value is based on a small sample study and nomogram based on age were not published. The determination of normal values in a population of healthy controls according to age appears to be a prerequisite for reliable interpretation of imaging data.

Moreover, myocardial edema and fibrosis are more and more evaluated with cardiac MRI using T1 and T2 myocardial relaxation times. As for T2\* values, normogram of T1 and T2 values based on age were not published.

The increasing use of T1, T2 and T2\* mapping sequences in clinical practice for tissue characterization of the myocardium justify the implementation of a study in healthy volunteers to determine normograms based on age.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers over the age of 18 and less than 70
* Volunteers able to understand and sign the consent and to give written informed consent
* Female contraceptives if of childbearing age
* Registered or entitled to social security system
* Volunteers able to maintain supine for 20 minutes

Exclusion Criteria:

* Major protected/under guardianship
* Volunteers unable to maintain the supine position for 20 minutes
* Claustrophobia
* Volunteers with history of PRBC transfusion
* Volunteers with history of hematologic disease or a disruption of iron status
* Volunteers with history of cardiac disease including arrhythmias
* Hypertension
* Diabetes
* Contra-indication for MRI: metal fragments in the eyes; implantable cardiac, neurological or ENT device; osteosynhesis material not compatible with MRI
* Women who are pregnant or likely to be
Waveform Periodicity Analysis of Complex Fractionated Electrograms in Patients With Persistent Atrial Fibrillation

Atrial fibrillation (AF) has been the most frequently occurring, sustained arrhythmia, which causes significant morbidity and mortality. AF may not always be a totally random process. It can be maintained by stable and rapid reentrant circuits resulting in fibrillary conduction throughout the atria. During mapping of AF, difficulty is frequently encountered during the identification of culprit sites and an analysis of the wave propagation particularly when the electrogram signals demonstrate wide temporal and spatial disparities. Catheter ablation targeting regions with fractionated potentials or high frequencies during AF, has been previously proposed as a treatment strategy. However, the benefit of adjunctive CFAE (complex fractionated atrial electrogram) ablation or linear ablation after successful PVI (pulmonary vein isolation) was controversial based on the recent data from the Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II (STAR AF II) trial. Therefore, the optimal ablation strategy for persistent AF remains undetermined and an alternative approach has to be explored.

In this prospective trial, investigators will investigate the long-term efficacy of catheter ablation of non-paroxysmal AF, based on selective atrial substrate modification (e.g. wavefrom periodicity analysis, similarity, plus phase mapping) (1). The control group would be PV isolation alone. The primary end point is long-term recurrence of atrial arrhythmias. The secondary end points composite procedural termination, the safety of the procedure, recurrence of multiple procedures, and change of atrial and ventricular function after catheter ablation.

The inclusion criteria, exclusion criteria, stepwise catheter ablation procedures (PVI and then substrate modification), and the follow-up procedure are the same as current treatment approaches in patients with non-paroxysmal AF.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who sign the informed consent forms, and allow to be followed.
2. Symptomatic AF refractory or intolerant to at least one Class 1 or 3 antiarrhythmic medication.
3. Patients with persistent/permanent AF (sustained beyond seven days, or lasting less than seven days but necessitating pharmacologic or electrical cardioversion).
4. Patients with age equal or greater than 20 years old regardless of gender.

Exclusion Criteria:

1. The presence of a atrial or ventricular thrombus.
2. Patients who are allergic to or unsuitable for use with the contrast media.
3. Pregnant patients or patients who are unavailable to receive X-ray.
4. Patients with renal insufficiency.
5. Patients had autonomic nervous system disorder (e.g. respiratory apnea) or previous catheter ablation in the LA or MAZE procedure.
6. Patients who do not need atrial substrate modification (patients with non-paroxysmal AF respond to PVI in terms of procedural termination of AF).
7. Patients with age less than 20 years old or greater than 90 years old regardless of gender.
A Study to Identify and Characterise Patients With Chronic Kidney Disease and Proteinuria

The purpose of the D4325C00007 study is to identify and characterise patients with known or newly diagnosed CKD for possible participation in future renal clinical studies and to obtain an overview on current treatment choices for this patient group in different regions.


Eligibility Criteria:
Inclusion criteria:

1. Male or female aged ≥ 18 years at the time of signing the informed consent
2. Express interest to participate in a future CKD clinical study
3. eGFR ≥ 20 to \< 90 mL/min/1.73 m2 (eGFRcr\[AS\], Section 8.2.1) (Delgado et al 2022, Inker et al. 2021)
4. UACR ≥ 700 mg/g or UPCR ≥ 1000 mg/g based on urine sample at time of screening visit
5. Receiving RAS inhibitor therapy (ACEi or ARB) that has been at stable dosing for at least 4 weeks. Exceptions from this requirement will be made for participants who are unable to tolerate RAS inhibitor therapy
6. Provision of signed and dated written informed consent before any study-specific procedures

Exclusion criteria:

1. Known NYHA class III or class IV Congestive Heart Failure at the time of enrolment
2. Known T1DM
3. Known history of any life-threatening cardiac dysrhythmia (continuous or paroxysmal)
4. Known history of solid organ transplantation
5. Known history or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2i (eg, dapagliflozin, canagliflozin, empagliflozin) or endothelin receptor antagonists (eg, ambrisentan, atrasentan, bosentan)
6. Known blood-borne diseases such as specified in Appendix B (category A and B)
7. Known pregnancy at the time for the visit or have an intention to become pregnant
8. Lupus nephritis, anti-neutrophil cytoplasmic autoantibody vasculitis, minimal change disease, autosomal dominant polycystic kidney disease (polycystic kidney disease), Alport syndrome, patients on renal replacement therapy, or clinical nephrotic syndrome with problematic oedema
A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)

1. Investigational Product

   1. Imatinib mesylate tablet 400 mg
   2. Glivec film-coated tablet 100 mg (Comparator)
2. Expected target disease

   1. chronic myeloid leukemia
   2. Gastrointestinal stromal tumors
3. Study design : Randomized, open-label, single dose, two-period, two-way, crossover study

   1. 36 healthy subjects, 2 groups (18 subjects/group)
   2. 2 Period (either 1-a(1 tablet) or 1-b(4 tablet))
   3. wash-out period : 14 days
4. Evaluation on pharmacokinetics(PKs) and safety

   1. PKs : Cmax, AUClast, Tmax, AUCinf, t1/2
   2. safety : adverse events, physical examination, vital sign, ECG, Laboratory test
5. Statistical method

   1. Demography Characteristics
   2. Pharmacokinetic parameters
   3. Safety data


Eligibility Criteria:
Inclusion Criteria:

* healthy male volunteers between the ages of 20 to 50 years old
* weight more than 55kg and within the range of ±20% of ideal body weight (IBW)
* having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
* doctor determines to be suitable as subjects within 3 weeks ago before administration

Exclusion Criteria:

* Hypersensitivity(or history of hypersensitivity) to medicines including imatinib mesylate
* Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT, total bilirubin
* Creatinine clearance \< 80 mL/min
* Gastrointestinal diseases or surgeries that affect absorption of drug
* Excessive drinking(exceed 21units/week)
* Smoking over 10 cigarettes per day
Safety and Efficacy on Cell-based Therapy in Patients With Recent Large Acute Myocardial Infarction

The purpose of this study is to test bone marrow mononuclear cells for patients with recent heart attack who are at high risk of experiencing heart failure. This study drug is made of you own cells. Studies similar to this one have suggested that the use of cell-based transfer after heart attack can improve the recuperation of the heart. The purpose of this study is to assess whether cell transfer can improve the healing of the heart after a heart attack.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age and no more than 80 years of age.
* Acute ST-segment elevation MI
* Symptoms suggestive of acute MI
* ≥ 2mm ST-segment elevation in 2 or more precordial leads or ≥ 1mm in or more limb leads or new left bundle branch block
* Time from symptom onset to enrollment \< 120 hours
* Left ventricular dysfunction by contrast ventriculography or echocardiography
* EF above 25 % and lower than 40%
* Focal wall motion akinesis or dyskinesis
* Clearly identifiable infarct artery
* Patent infarct artery (TIMI flow grade 2 or 3) of ≥ 2 mm in diameter following successful stent placement

Exclusion Criteria:

* Planned treatment with bypass surgery or prior CABG
* Multi-vessel PCI
* Prior myocardial infarction by history or presence of pathologic Q-waves
* Active cardiogenic shock: mechanical ventilation, IABP, or vasopressors/inotropes
* Successful reperfusion \< 3 hrs from symptom onset
* Prior MI or significant chronic heart failure
* Pacemaker/defibrillator
* Contraindication to MRI (metallic foreign body, claustrophobia, inability to lie flat)
* Significant hepatic dysfunction or renal insufficiency (estimated creatinine clearance\<25 and/or serum Cr \>2.5 mg/dl)
* Baseline hematocrit \< 30
* Pregnancy, or lactation/parturition within the past 30 days
* Active or planned treatment with chemotherapy
* Anticipated difficulty with 90-day follow-up
* Evidence of a serious, active infection in the opinion of the investigator including, but not limited to subjects who are HIV, hepatitis B or C positive
* Any known severe hematological disease, malignancy, systemic or life threatening disorder that would be incompatible with the trial
* Previous enrollment in this trial
* Participation in an investigational drug or device study within the past 30 days
SipSmarter: A Nutrition Literacy Approach to Reducing Sugary Beverages

The primary aim of this pragmatic randomized-controlled trial was to determine the effectiveness of a scalable 6-month intervention aimed at decreasing SSB consumption (SIPsmartER) when compared to a matched contact physical activity promotion control group (MoveMore).

The primary aim of this application targeting at-risk residents from rural southwest Virginia counties is to:

1. Determine the effectiveness of SIPsmart and SIPsmartER at decreasing SSB consumption when compared to a matched contact control group targeting walking behaviors.

The secondary aims are to:

1. Explore causal pathways through which changes in SSB attitudes, subjective norms, and perceived behavioral control influence behavioral intentions and SSB consumption, and the extent to which changes in SSB consumption are mediated by changes in nutrition numeracy and nutrition-related media literacy.
2. Determine the reach and representativeness, adoption feasibility, degree to which the intervention was implemented as intended (and associated costs), and the maintenance of behavior changes 6 and 12 months post intervention (i.e., 18 months from baseline) when compared to control.
3. Assess intervention impacts on body weight.

An exploratory aim is to:

1. Assess intervention impacts on a 13C biomarker, a new non-invasive biomarker fingerstick technique for added sugar intake, and evaluate the changes in this biomarker over time.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria included English-speaking adults \>18 years of age, who consume \>200 SSB kcals/day, self-report no contraindications for physical activity, and have regular access to a telephone.

Exclusion Criteria:

* To minimize potential confounds, only one member per household is eligible to enroll and individuals cannot be concurrently enrolled in a Cooperative Extension program because these programs focus on improving nutrition.
Genetic Analysis of Liver Cancer

Liver cancer is a leading cause of cancer deaths worldwide. While the molecular pathogenesis of liver cancer has been extensively studied, less is known about how the molecular biology of liver cancer influences clinical outcome and treatment response. We are developing a translational research program that will characterize molecular changes in liver cancer. We plan to use molecular information obtained from studying liver tumor tissues to develop new diagnostics and treatment regimens for patients with these cancers. The experimental approach will require freezing fresh tumor tissues obtained from surgical procedures, which will be subsequently used for analysis of DNA, protein and mRNA expression. Many patients with liver cancer are referred to the Stanford Liver Tumor Board for consultation and treatment recommendations. We propose to gather tissue samples from those who subsequently undergo biopsy, liver resection surgery, or transplant surgery.


Eligibility Criteria:
Inclusion Criteria:3.1.1 Male or female patients 18 years of age and above. 3.1.2 Patients diagnosed with liver cancer based on biopsy or serum alpha-fetoprotein level, associated with characteristic hypervascular liver tumors on triphasic spiral CT scan or MRI. Patients with non-cancer liver conditions such as cirrhosis, adenoma, cholangioma, or nodular hyperplasia. Patients with metastatic tumor from anther organ, such as metastatic colon cancer.

3.13 Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria:3.2.1Female patients who are pregnant or nursing will be excluded from the study.
Effects of Exercise Intensity on Energy Intake, Appetite and Enjoyment in Overweight and Obese Females

Interval exercise involves short bouts of high intensity exercise interspersed with periods of lower intensity exercise. The benefit is that a shorter total duration of exercise may be required to achieve cardiovascular benefits similar to or even superior to traditional longer bouts of steady state endurance exercise. However how this type of exercise affects appetite and energy intake, particularly in overweight and obese females is not well known.

This study involves two trials of exercise, one at high intensity and one at low intensity, followed by a buffet lunch, in overweight and obese females.


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Adult
3. apparently healthy
4. overweight or class I obese
5. eumenorrheic

Exclusion Criteria:

1. Diabetes
2. pregnancy
3. cardiovascular disease
4. greater than 1 hour of structured physical activity per week
5. thyroid disease
6. polycystic ovary disease
The Effectiveness of Two Osteoporosis Drugs on Prosthetic Bone Mineral Density (BMD) Loss After Total Hip Arthroplasty(THA)

The purpose of this study is to evaluate whether alendronate and alfacalcidol are effective on prosthetic or lumbar spine BMD after total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis of the hip
* patients after total hip arthroplasty

Exclusion Criteria:

* diseases related to bone metabolism
* patients taking drugs which affect bone metabolism
A Clinical Study Evaluating the Safety, Tolerability and Initial Efficacy of SKG0106 Intravitreal Injection in Diabetic Macular Edema (DME) Patients

This is a clinical study to evaluate the safety, tolerability and initial efficacy of SKG0106 intravitreal injection in diabetic macular edema (DME) patients.

This is an open, dose-escalation clinical study to evaluate the safety, tolerability and initial efficacy of SKG0106 intravitreal injection in diabetic macular edema (DME) patients in China.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained prior to all assessments.
* Age ≥18 years at screening.
* Type 1 or type 2 diabetes mellitus at screening.
* Study eye criteria:

  * Decreased visual acuity attributable primarily to DME.
  * DME involves the macular center.

Exclusion Criteria:

* Active proliferative diabetic retinopathy in the study eye.
* Any current or previous ocular disease in the study eye other than DME that could interfere with macular evaluation or affect central vision at screening or baseline.
* Any active intraocular or periocular infection or active intraocular inflammation of the study eye at screening or baseline.
* History of idiopathic or autoimmune uveitis in the study eye at screening or baseline.
* Prior gene therapy in either eye.
* History of vitreoretinal surgery in the study eye.
* Uncontrolled blood pressure at screening or baseline defined as systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg.
* History of treated or untreated malignancy of any organ system within the past 5 years.
* Pregnant or lactating women.
* Women of reproductive age, defined as all women who are biologically capable of being pregnant, unless they use highly effective contraceptive methods between the time of study drug administration and 3 months after EOS (end of study).
Comparing Two Surveillance Approaches for People Who Have Received Treatment for HPV-associated Head and Neck Cancer and Show No Signs of Disease

The purpose of this study is to compare standard surveillance with telemedicine surveillance (tele-surveillance) and find out which surveillance approach is best for people with HPV-associated head and neck cancer who have no evidence of disease after treatment. The researches will look at how the two approaches affect participants' quality of life, health outcomes, and expenses (for example, costs of routine visits and procedures). They will also determine doctors' and patients' satisfaction with tele-surveillance.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* ECOG 0-3
* Pathologically (histologically or cytologically) diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls)
* No evidence of disease on post-treatment PET/CT within 9 months of completing radiation therapy. No evidence of disease is a consensus determination by the patient's radiation, medical, and surgical oncologist. If the first PET/CT is equivocal, then a second PET/CT can be obtained within 9 months of completing radiation therapy.
* Post-treatment diagnostic imaging with either CT or MRI (recommended but not required)
* Able to speak and read English fluently
* Able to provide informed consent

Exclusion Criteria:

* Patients on clinical trials related to head and neck cancer that have protocol defined follow up activities
* Incomplete response or recurrent disease on post-treatment PET/CT
* Completion of radiation and chemotherapy more than 9 months ago
Study of the Health Information Needs of Brain Cancer Patients

The purpose of this research is to explore the factors involved in brain cancer health care literacy needs.

A mere subset of the reasons behind unmet health care literacy needs include the health care systems' increasing complexity, increased time constraints, profound treatment decision making requirements, decreased financial resources, fracturing social networks and diversifying educational and cultural needs.

This project will use focus groups to explore the factors involved in brain cancer health care literacy from the perspectives of patients and those involved in their care. Hypothesis generated from this project will be directly applied toward future projects. The overarching goals are improved access and adequacy of health care literacy information through the eventual development of validated, useful, reliable health care literacy information tools for brain cancer patients and those involved in their care.

Eligibility Criteria:
Inclusion Criteria:

BRAIN TUMOR PATIENTS:

* 18 to 89 years of age
* Have or have had any type of brain tumor
* Ability to communicate in English
* Willingness to participate in a 30-60 minute focus group

HEALTH CARE PROVIDERS:

* 18 to 89 years of age
* Be a health care provider who cares for any type of brain tumor
* Ability to communicate in English
* Willingness to participate in a 30-60 minute focus group

Exclusion Criteria:

* None
RIAT Registry: Reason for Not Intensifying Antihypertensive Treatment

To support physicians in their active management of hypertensive patients. By targeting specific systolic and diastolic blood pressure (BP) figures physicians will closely monitor the BP values and as such will have an individualized control of the treatment in each patient.


Eligibility Criteria:
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:

* Adult hypertensive
* Either newly diagnosed and untreated
* or previously treated and uncontrolled Patients of both sexes with essential hypertension

Exclusion Criteria:

* Known secondary hypertension
* Known secondary curable hypertension (i.e. pheochromocytoma, aldosterone producing adenoma, Cushing disease). Patients with renal disease are not excluded.