cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial to Evaluate the Safety and Efficacy of IBS Angel in Patients With Pulmonary Artery Stenosis

This is a prospective, multi-center, single-arm clinical trial to evaluate the safety and efficacy of Iron Bioresorbable Scaffold System (IBS Angel) in patients with pulmonary artery stenosis.

82 patients with pulmonary artery stenosis will be treated with the Iron Bioresorbable Scaffold System (IBS Angel) developed by Biotyx Medical (Shenzhen) Co., Ltd. This study is designed as a prospective, multi-center, single-arm clinical trial. Enrolled patients will undergo IBS Angel implantation and will be followed up at 1, 3, 6, 12, and 24 months post-procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must between 1 and 14 years old.
2. Patients who have congenital or secondary pulmonary artery stenosis (including pulmonary artery trunk, left pulmonary artery and right pulmonary artery), and meeting one of the following criteria:

   A: The pressure gradient across the stenosis ≥20mmHg measured by catheter; B: The degree of pulmonary artery stenosis ≥50% ( calculated by (diameter of adjacent normal segments - residual lumen diameter of the stenosis segment)/diameter of adjacent normal segments ×100%); C: The ratio of right ventricular systolic pressure to aortic systolic pressure ≥50%.
3. Patients and whose family have high compliance, voluntarily participate in and sign the informed consent form, and complete the 2-year follow-up.
4. Patients have life expectancy \>2 year after successful stent implantation.

Exclusion Criteria:

1. Patients who have a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc.
2. Patients with cardiopulmonary function that cannot tolerate surgery, such as severe heart failure (NYHA Grade III and above) that cannot be controlled by active medical treatment.
3. Patients with known allergy to contrast agent, iron and its degradation products.
4. Patients with hemorrhagic disorders.
5. Patients with contraindications on antiplatelet agents and anticoagulant therapy.
6. Patients with thrombosis at the vascular wall of target lesion or the distal or proximal location.
7. Patients with known severe renal or hepatic insufficiency which are unsuitable for index procedure as per investigator judgement.
8. Previous stent implantation has been performed to treat the target lesion;
9. Patients with severe stenosis or excessive tortuosity in the targeted vessels, or anatomical abnormalities, making it difficult for device to reach the target lesion.
10. Other conditions that are not suitable for stent delivery or balloon expansion.
11. Patient who have already participated in another drug or medical device clinical trial that have not yet completed or withdrawn within 3 months before the screening period of this trial.
12. Patients who are not suitable for participating the trial as per investigator judgement.
Comparison of Diagnostic Rest/Stress SPECT Results for Patients With Myocardial Ischemia and Infarction Using Myoview in Both Single and Dual Isotope Acquisition Approaches

The study is designed to determine whether a dual isotope protocol is equivalent to a single isotope in the diagnosis of myocardial ischemia and infarction using MYOVIEW SPECT imaging.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is 18 years old or older.
2. Male subjects or non-lactating female subjects, who are either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or for women of childbearing potential, the results of a serum or urine human chorionic gonadotropin pregnancy test, performed at screening within 24 hours before dosing (with the result known before investigational medicinal product administration) must be negative.
3. The subject is able and willing to comply with study procedures (i.e., 1 SPECT imaging at Stress, 2 SPECT imagings at Rest) and signed and dated informed consent is obtained.
4. The subject is suspected of or known of having CAD based on the subject's clinical signs, symptoms, or examinations .
5. The subject is referred for Rest/Stress (exercise or pharmacological) MPS-SPECT for known or suspected CAD (as clinically required).

Exclusion Criteria:

1. The subject was previously included in this study.
2. The subject received an IMP within 30 days before or is scheduled to receive one during or in the next 30 days after IMP administration.
3. The subject has known allergies to any product used in this study or its constituents, including subjects who are not able to exercise and have contraindications to Adenosine (e.g., Asthmatics).
4. The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month.
5. The subject has no contraindications to any of the study procedures (e.g. physical exercise) or the involved drugs (Myoview, Thallium-201, Adenosine or Dipyridamole) such as e.g. 2nd or 3rd degree AV-block, SS syndrome, bradycardia, bronchoconstrictive or bronchospastic lung disease.
Spironolactone on Fibrosis Progrssion-Portal Hypertension(FP-PH)in Cirrhosis

The aim of this study is to investigate the effects of spironolactone on liver fibrosis progression and portal pressure gradient in patients with advanced chronic liver disease. Eligible cirrhosis patients were 2:1 randomized to either combination (carvedilol and spironolactone) or single (carvedilol) therapy group. Changes in virtual portal pressure gradient (vPPG) of portal trunk (calculated based on reconstructed 3D model and measured blood flow velocity), liver stiffness measurement (Fibroscan) and serum markers of liver fibrogenesis were documented at baseline and six months later.


Eligibility Criteria:
Inclusion Criteria:

-Proven cirrhosis based on histology or unequivocal clinical, sonographic and laboratory findings

Exclusion Criteria:

* Treatment with β-blockers or diuretics in the last 3 months
* Severe cardiopulmonary or renal insufficiency
* Chronic alcohol abuse
* Can't tolerate side effects of oral carvedilol or spironolactone
* History of variceal bleeding
* Malignancy
* Portal vein thrombosis
* History of partial splenic embolization or splenectomy
* Moderate or tense ascites
Applications Site Reactions After Injection of Insulin Detemir and Saline in Subjects With Diabetes

To compare application site reactions after superficial and deep subcutaneous and intradermal injections of insulin detemir and saline in patients with diabetes

- The patient serves as his own control, n=100 patients with diabetes


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus
* HbA1c\<11 %
* BMI: 20-35 kg/m2
* Insulin detemir naive
* Basal insulin dose\>20E

Exclusion Criteria:

* Known allergy to study drug
* Current steroid or antiallergic treatment
* Lipodystrophy
* Change in insulin and antihypertensive treatment \< 30 days
* Smokers or alcoholics
The Effects on Cognitive Function of Levetiracetam (Keppra®) Compared to Carbamazepine (Tegretol®, Carmazepine®) as Monotherapy for Children With Partial Seizure; A Multicentric Randomized Controlled Study

Unlike the first generation antiepileptic medications, newer drugs for epilepsy such as levetiracetam are reported to have less adverse effect in children but not many studies have systematically reviewed the subject. This study aims to prospectively evaluate the effect of levetiracetam on neurocognition, behavioral issues and quality of life, as well as its seizure control efficacy and other adverse events in pediatric epilepsy patients, in comparison to carbamazepine, one of the classic antiepileptic medication, widely prescribed for both partial and generalized seizures, despite its well known side effects.

This multicenter, open-label, parallel-group trial is expected to enroll 130 patients from age 4 to 16 woh will be randomized into two groups, which will be prescribed with levetiracetam or carbamazepine. Series of neuropsychological assessment and behavioral and life evaluations of the patients will be performed at baseline period and after the 52 weeks of study period.


Eligibility Criteria:
Inclusion Criteria:

1. Patients from age 4 to 16, who have been diagnosed with focal epilepsy
2. Patients who have experienced minimal two unprovoked seizures, or patients who have had one unprovoked seizure and have shown focal abnormality in the EEG
3. Patients who have not received any antiepileptic medications prior to the study (Those who have been treated with rescue medication are eligible)
4. Patients with eligible consent or with legal guardians have given official consent

Exclusion Criteria:

1. Patients with progressive CNS disease, or systemic illness
2. Patients with level of SGOT/SPGT above the doubled normal level or BUN/Creatinine above the 3 times of the normal range
3. Patients who had used other anti-epileptic medication during any period of the trial, including baseline period. (Benzodiazepine used as rescue therapy is acceptable)
4. Patients who show hypersensitive reaction to the study medication.
5. Patients with any psychological problems.
6. Patients deemed inappropriate for the study by the investigators
Estrogen Receptor Variants, HDL, and Atherosclerosis

To measure the association between estrogen receptor variants and the extent of atherosclerosis in the thoracic and abdominal aorta and the right coronary artery in subjects in the PDAY study.

BACKGROUND:

Increased levels of HDL cholesterol are associated with lower rates of clinical and anatomic atherosclerosis, even in adolescents and young adults. In premenopausal women, estrogen-associated increases in HDL may account for their low rates of coronary heart disease (CHD) events. Recently, a sequence variant in the estrogen receptor-alpha (ER-alpha) gene, ER-alpha IVS1-397 T/C), has been linked to twofold greater increases in HDL cholesterol in response to hormone replacement therapy (HRT). However, it remains unclear whether this sequence variant also augments HDL levels in the setting of premenopausal estrogen exposure and whether such differences translate into greater reductions in atherosclerosis risk. The study uses the cohort of the Pathobiology of Atherosclerosis in Youth (PDAY) study, a large cross-sectional autopsy study of the extent of atherosclerosis in subjects aged 15 to 34 years. The detailed descriptions of atherosclerotic lesions, combined with data on cardiovascular risk factors and access to tissue for DNA extraction, makes this an ideal cohort in which to examine the association between ER-alpha IVS1-397 genotypes, HDL levels, and development of early atherosclerosis.

DESIGN NARRATIVE:

The overall goal for this study is to measure the association between the estrogen receptor (ER- IVS1-401 T/C) polymorphism and extent of abdominal aorta, thoracic artery, and right coronary artery atherosclerosis in Pathobiological Determinants of Atherosclerosis in Youth (PDAY) subjects. The investigators will use DNA extracted from liver specimens in order to measure the ER polymorphisms. The extent of atherosclerosis will be defined as the percent of intimal area involved with fatty streaks or raised lesions, using previously established PDAY definitions. However, percent involvement of fatty streaks alone and the percent involvement of the individual components of raised lesions (fibrous plaques, complicated lesions, and calcified lesions) will be analyzed separately. Available data on risk factors (smoking, diabetes, hyperlipidemia, hypertension) will permit reducing confounding of the results by allowing adjustments for effects of the major risk factors for coronary heart disease. The Department of Pathology at Louisiana State University Health Sciences Center (LSUHSC) has been designated by the National Heart, Lung and Blood Institute to centralize, maintain, and distribute the valuable material collected through the combined efforts of the cooperating institutions for further studies in atherosclerosis. LSUHSC will provide DNA for polymorphism analysis and assist in data analysis. Polymorphism determination will occur at Wake Forest.

Eligibility Criteria:
No eligibility criteria
(ARFI) Shear Velocity Imaging of the Kidneys in Pediatric Patients

Urine reflux (urine backing up into the kidneys) is common in the pediatric population and may be complicated by renal abnormalities, such as infection and scarring. Currently, urine reflux is detected using either voiding cystourethrogram or other procedures. A new technique called ultrasound-based Acoustic Radiation Force Impulse (ARFI), or shear wave velocity imaging SVI) is performed using standard approved ultrasound machines and transducers bu the sound waves/impulses are produced in a different pattern. We hope to evaluate the usefulness of ARFI in diagnosing possible kidney damage caused from urine reflux (urine backing up into the kidneys).


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age and younger
2. Are scheduled to have a clinically ordered kidney ultrasound and a voiding cystourethrogram (to evaluate urine reflux) on the same day. -

Exclusion Criteria:

None to list
Ezetimibe and Atorvastatin Therapy on TCFA

After successful coronary angiography and OCT examination, patients with TCFAs in non-culprit, mild-to-moderate stenotic lesions will be enrolled. Then, they will be randomly assigned in a 1:1 ratio to receive either atorvastatin (20 mg/day) alone or atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）by envelope method. Angiographic and OCT follow-up will be scheduled for the target vessel after 12 months.

This is a prospective, randomized , controlled, open-label, single-center study to evaluate the effect of ezetimibe added to atorvastatin on coronary thin-cap fibroatheroma(TCFA). After successful coronary angiography and OCT examination, patients with TCFAs in non-culprit, mild-to-moderate stenotic lesions will be enrolled. Then, they will be randomly assigned in a 1:1 ratio to receive either atorvastatin (20 mg/day) alone or atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）by envelope method.

Angiographic and OCT follow-up will be scheduled for the target vessel after 12 months.The primary efficacy endpoint is the change in minimum fibrous cap thickness measured by OCT from baseline to follow-up.The secondary endpoints include absolute and percent changes in the lipid, glycemic, and inflammatory profile. Then, changes of these indicators above will be compared respectively in diabetic and non-diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

1.stable angina or acute coronary syndrome 2.18-80 years old 3.hypercholesterolemia :total cholesterol level \>220 mg/dl (5.7mmol/L) and/or LDL-C level \>140 mg/dl(3.6mmol/L), or previously receiving statins therapy 4. the target vessel for OCT interrogation has not undergone angioplasty and has angiographic diameter stenosis from 25% to 75% 5.There are TCFAs in non-culprit, mild-to-moderate stenotic lesions above

Exclusion Criteria:

1. administration of lipid-lowering drugs other than statins before enrollment
2. significant stenotic lesions in all coronary vessels
3. severe congestive heart failure (New York Heart Association class IV) ,or left ventricular ejection fraction\<35%
4. more than 3 times of the upper limit of normal (ULN) in the creatine kinase (CK) and the transaminase level before enrollment and no relation with myocardial infarction
5. renal failure (serum creatinine\>2.0 mg/dL）
6. hypersensitivity to x-ray contrast media, statin，clopidogrel or ezetimibe
7. Others: terminal stage cancer,a positive pregnancy test
The Effect of Time-Restricted Eating in Cardiometabolic Health

Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-12 h/day with no energy intake the rest of the day. In rodents, TRE improves metabolic function without caloric restriction, potentially by activating nutrient sensing mechanisms and effects on circadian oscillations. However, an understanding of the effect of TRE on cardiometabolic health in people is not clear and few studies have evaluated this issue. Accordingly, the investigators propose to conduct a randomized controlled trial in people with obesity and prediabetes to determine the effect of 9 h TRE for 12 weeks, without a change in body weight, on key metabolic outcomes that are risk factors for cardiovascular disease (CVD): 1) multi-organ insulin sensitivity; 2) 24 h metabolic homeostasis and diurnal rhythm; and 3) adipose tissue and skeletal muscle biology. The proposed studies will elucidate the cardiometabolic implications of TRE in people with obesity and prediabetes.


Eligibility Criteria:
Inclusion Criteria:

* body mass index 30-39.9 kg/m2
* fasting plasma glucose 100-125 mg/dl, or 2h OGTT plasma glucose 140-199 mg/dl or hemoglobin A1C 5.7-6.4%
* self-reported habitual eating period \> 15 h per day

Exclusion Criteria:

* shift worker, recent or expected travel crossing time zones
* fasting \>12 h/day more than once a week or vegan
* shift worker, recent or expected travel crossing time zones
* fasting \>12 h/day more than once a week or vegan
* \> once a week no food intake after 1800 h
* habitually waking up before 0400 h and sleeping before 2230 h
* ≥ 150 min per week of structured exercise
* unstable weight (\>5% change the last 2 months)
* type 2 diabetes or other major chronic disease
* sleep disorder
* cancer in last 5 years
* conditions that render subject unable to complete all testing procedures
* use of medications that affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued (e.g., steroids, alpha or beta adrenergic blockers or agonists, etc.)
* smoking and illegal drug use
* pregnant or lactating
* menopause
* individuals that have performed procedures involving substantial exposure to radiation in the last 12 months
* gastrointestinal or bariatric surgery
* unable to grant voluntary informed consent or comply with the study instructions
* individuals who are not yet adults (infants, children, teenagers)
* prisoners
Ginger Capsules for the Acute Treatment of Migraine Attacks

The main objective of the study was to evaluate ginger efficacy as an adjuvant to ketoprofen for the treatment of headache and other symptoms related with migraine attacks.

Patients with the diagnosis of migraine according to the International Headache Society (IHS) criteria were enrolled in the study during a migraine attack. Patients received two 200 mg capsules of dry ginger extract (5% active ingredient) or two capsules of placebo (cellulose) in addition to an intravenous dose of ketoprofen (100 milligrams - mg) to treat the migraine attack.

Eligibility Criteria:
* Inclusion Criteria:

  * Migraine diagnosis for at least one year;
  * Migraine attack with moderate or severe pain intensity;
  * One to six migraine attacks per month.
* Exclusion Criteria:

  * Patients with headaches not characterized as migraine;
  * Pregnant or lactating women;
  * Fertile and sexually active women who do not use contraception;
  * Abuse of painkillers, alcohol or drugs;
  * People with hypersensitivity to ginger;
  * People with other neurological diseases;
  * People in use of anticoagulant drugs;
  * People who have started the disease after 50 years old.
An Observational Study to Evaluate Impact of CRP-Level on Real World Effectiveness of Upadacitinib as Monotherapy or in Combination With MTX in Adult Participants With Rheumatoid Arthritis

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. RA can reduce the ability to perform everyday tasks. This study assesses whether C-reactive protein (CRP)-level has an impact on achieving remission with upadacitinib when used alone or in combination with methotrexate (MTX). This study will also assess the reduction in pain, morning stiffness, fatigue, functionality, health status and impact of RA.

CRP is an indicator of inflammation and often used for disease activity monitoring during RA treatment. Upadacitinib is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate. This study has two groups - upadacitinib monotherapy and combination. Adult participants with moderate to severe RA will be enrolled. Around 500 participants will be enrolled in the study in multiple sites within Germany.

Participants will receive upadacitinib alone or in combination with MTX per their physicians' usual prescription. Individual data will be collected for 12 months.

No additional study-related tests will be conducted during the routine physician visits. Only data which are routinely collected during a regular visit will be utilized for this study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe active rheumatoid arthritis (RA) upon judgment of the treating physician.
* Swollen Joint Count (SJC) \>= 3 of 28 joints of the Disease Activity Score (DAS)28.
* Measurement of C-Reactive Protein (CRP)-level at Baseline (BL) or \<= 4 weeks prior to BL at a timepoint when the Prednisolone equivalent dose of Glucocorticoid treatment was \<= 10 mg/day for at least 7 days.
* Upadacitinib treatment is indicated as per local Summary of Product characteristics (SmPC).
* Decision on the treatment with Upadacitinib was made prior to any decision to approach the patient to participate in this study.

Exclusion Criteria:

* Participants who cannot be treated with Upadacitinib according to the local Upadacitinib SmPC.
* Prior treatment with Upadacitinib.
* Treatment with Sarilumab or Tocilizumab within the last 8 weeks before the CRP level for inclusion was measured.
* Participants currently participating in interventional research.
* Participants who are unwilling or unable to complete the patient reported questionnaires.