cyrilzakka/clinical-trials huggingface dataset:
Pharmacogenetics of Hypertriglyceridemia in Hispanics

To study the effect of genes on lipid-lowering drug treatment in hypertriglyceridemia.

BACKGROUND:

Increased serum triglycerides are a significant independent risk factor for coronary artery disease and myocardial infarction. Besides typical lifestyle modification, the treatment with fibrates is standard in patients with hypertriglyceridemia. There is ample evidence that genetic factors influence triglyceride levels. Identifying genes, which affect triglyceride levels and moreover determining the response to fibrates is of great interest. Hispanics are among the populations with the highest prevalence of this disease. Therefore focusing on a high-risk population further adds to the overall significance of this study. Identifying genes and genetic mechanisms contributing to the treatment response can lead to new or improved treatment methods.

DESIGN NARRATIVE:

The study tests the hypothesis that differences in therapeutic effects of fibrates are related to variations in networks of genes regulating lipoprotein metabolism. An efficient approach for identifying and categorizing major gene variants is based on determination of sequence haplotypes. Only Hispanics will be studied to provide a homogenous population for this genetic study. Furthermore, Hispanics are the fastest growing ethnic group in the U.S. and have a higher prevalence of hypertriglyceridemia than other ethnic groups. The investigators will measure plasma triglycerides (TG), other lipids and lipoproteins, and lipoprotein particle size before and after treatment with fenofibrate in 800 Hispanic individuals with hypertriglyceridemia. They will reconstruct the haplotypes of 16 candidate genes known to regulate TG metabolism and mediate the effect of fibrates. The associations between phenotypes and major haplotypes will be analyzed in a two stage design, with the first half of the sample serving a hypothesis-generating function. Those candidate gene haplotypes that are found to be associated with quantitative traits and drug responses in the first half of the sample will then be tested for confirmation in the second half. In addition, data from the full cohort will be analyzed to identify additional pharmacogenetic associations that may require greater statistical power. Finally, direct fine mapping will be performed in the four most promising genes to identify the responsible variations.

Eligibility Criteria:
Hispanics with hypertriglyceridemia
Diabetes Mellitus Care Decision Making Model Through Data Mining

We tried to use data mining method to find out the new model of factors that affects the progression of diabetes mellitus.

The advanced development of medical technology had led to the accumulation of a large amount of medical data. Unfortunately, these useful and meaningful clinical data were not properly managed or analyzed. Therefore, data mining technology has become an essential instrument for hospital management and medical research. Possible meaningful information can be obtained from the database through data mining. About 2,000 diabetic patients had been enrolled in Diabetes Care Program since Oct 2002 in our hospital. We intend to look for the determining factors that affect the prognosis of diabetes mellitus in our patients group.

Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus who had been enrolled into the Diabetes Care Program from year 2002 until 2007.

Exclusion Criteria:

* none
Effects of Training of Pelvic Floor Muscles (MAP) on Stress Urinary Incontinence

In the current scientific literature, it is clear that SUI can cause several social, hygienic and personal relationship problems. It has also been proven that this condition affects many more menopausal women than menacme, and this is believed to be due to the hypoestrogenism characteristic of this phase.

On the other hand, weakness of the pelvic floor muscles (PFM) is also related to the genesis of SUI. The role of these muscles would be to keep the bladder neck elevated (above the pubic symphysis) during increases in abdominal pressure, and its weakness would lead to excessive lowering of the bladder neck at these times, leading to SUI due to bladder neck hypermobility.

The conservative treatment of this condition, therefore, encompasses the strengthening of PFMs, which would avoid excessive descent of the bladder neck during increases in abdominal pressure, thereby reducing urinary loss.

In the current literature there are studies proving the effectiveness of pelvic floor muscle training; however, in relation to the literature on abdominal hipopressive gymnastics, it is observed that the scientific evidence is still poor, however, the technique is still Widely spread through extension courses offered throughout Latin America, France and Spain; With regard to the comparison of these methods with respect to their clinical efficacy and the quality of life and patient satisfaction, there are no consistent studies, and this fact motivated us to carry out this study.


Eligibility Criteria:
Inclusion Criteria:

* Women with IUE and with a modified Oxford scale of at least 1.

Exclusion Criteria:

* Presence of neuromuscular diseases
* Uncontrolled diabetes
Transillumination to Reduce Post-injection Complications in Aesthetic Medicine

Transillumination (TL) is a noninvasive technique that appears to allow preliminary detection of superficial vascular structures of the face to avoid intravascular HA injection. The purpose of our study was to test the efficacy of TL in terms of its sensitivity to locate vessels in the areas undergoing treatment and to reduce post-injection vascular complications.

Transillumination was used during the injection of hyaluronic acid to reduce the risk of intravascular injection. For the purpose of randomization, patients were asked to choose a sealed envelope. Inside the envelope was a piece of paper indicating on which side of the face (right or left) the transillumination would be used.

For each filler injection, transillumination was used on one side; on the other side of the face, the injection was administered without the use of any vascular exploration method. After the vessels had been located on the side chosen for the transillumination technique, a skin-marker pencil was used to draw the vascular mapping of the upper part of the face, which in our opinion represented the area most at risk of complications, the middle and the lower parts of the face.

Then ice was applied on both sides of the face for 15 s before to proceed with the injections in order to cause vasoconstriction and to further decrease the risk of an intravascular injection.Transillumination sensitivity for locating the vessels of the face was assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for facial injections of hyaluronic acid

Exclusion Criteria:

* Patients with a history of allergy to a component of hyaluronic acid
* Patients with arteritis (Horton)
* Patients who have had previous facial surgery
* pregnant or nursing patients
68Ga-TCR-FAPI PET/CT in Patients With Various Types of Cancer

Adding targeted covalent radiopharmaceutical (TCR) moiety to fibroblast activation protein inhibitor (FAPI) can increase tumor uptake and tumor retention in pre-clinical studies. This study is an open-labeled single-arm phase II diagnostic clinical trial to explore the clinical value of 68Ga-TCR-FAPI PET/CT in suspected malignant tumor patients.

TCR-FAPI can covalently bind to FAP that increase tumor uptake and tumor retention in pre-clinical studies, which elevates the ability for cancer imaging and facilitates the targeted radionuclide therapy. This study is an open-labeled single-arm phase II diagnostic clinical trial to explore the clinical value of 68Ga-TCR-FAPI PET/CT in suspected malignant tumor patients. Quantitative features (i.e., SUVmax) will be calculated to evaluate the PET images. Alternative imaging modality, including but not limited to, Ultrasound, CT, MRI, and PET/CT with other radiotracers, might be applied according to clinical needs. For patients who took surgery after multiple examination, tumor tissue and histopathology will also be obtained. For patients who underwent other treatment, treatment response of each individual lesion will be observed.

Eligibility Criteria:
Inclusion Criteria:

* Suspected to have malignant tumors (supported by MRI and/or CT and/or tumor markers and/or pathology report), the tumor may be newly diagnosed or previously treated;
* Meet the indications for PET examination, show a clear indication and no contraindications;
* Have a performance status of score ≥ 80 on KPS scale or score 0-1 points on ECOG scale, a relatively good general situation;
* No major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection;
* Be ≥ 18 years of age;
* Be willing and able to understand the research content and provide written informed consent/assent for the trial.

Exclusion Criteria:

* Have a history of imaging agent allergies;
* Does not meet the PET-CT scan sedation requirements, or has contraindications for PET-CT examination;
* Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC

This is a multicenter, open-label, single-arm Phase II study to evaluate anti-tumor efficacy and safety of NT-I7 in combination with atezolizumab in subjects with PD-L1-expressing (TPS ≥ 1%), metastatic (Stage IV) or locally advanced squamous or non-squamous NSCLC who have not received prior systemic therapy in the metastatic or locally advanced setting. Eligible subjects must have measurable disease according to RECIST 1.1. This Phase II study will enroll up to 83 subjects.


Eligibility Criteria:
Inclusion Criteria:

* Have histologically or cytologically confirmed metastatic or locally advanced NSCLC, and have not received prior systemic therapy. Subjects with locally advanced disease must have Stage III NSCLC and are not candidates for surgical resection or definitive chemoradiation
* Tumor PD-L1 expression (TPS≥1%) as determined by PD-L1 22C3 immunohistochemistry local or central assay.
* Have measurable disease
* Agree to provide screening biopsy (or archival tissue) at screening to assess PD-L1
* ECOG 0-1
* Adequate hematologic and end organ function

Exclusion Criteria:

* Prior systemic anti-cancer therapy
* NSCLC with EGFR, or ALK, or BRAF or ROS or RED or other genomic tumor aberrations which have available therapy
* Prior radiotherapy within 2 weeks of start of study treatment
* Known active CNS metastasis or carcinomatous meningitis
* Severe reactions to mAbs or IV immunoglobulin preparations
* Autoimmune disease history in past two years
Transtibial Versus Anteromedial Femoral Tunnel Technique in ACL Reconstruction

The anteromedial (AM) portal technique was introduced to position the femoral tunnel in anterior cruciate ligament (ACL) reconstruction to more closely replicate the original footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated differences in these techniques with respect to clinical outcomes. The purpose of this study was to determine if there are any differences in clinical outcome between the AM and TT approaches.

The anteromedial (AM) portal technique was introduced to position the femoral tunnel in anterior cruciate ligament (ACL) reconstruction to more closely replicate the original footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated differences in these techniques with respect to clinical outcomes. The purpose of this study was to determine if there are any differences in clinical outcome between the AM and TT approaches.

Eligibility Criteria:
Inclusion Criteria:

* sustained a complete ACL tear and had no other ligament injuries requiring surgical intervention

Exclusion Criteria:

* concomitant collateral ligament tears
* significant chondromalacia (based on diagnostic imaging)
* previous lower limb surgery
* significant injury to either lower limb requiring surgery
* history of arthritis
* were unable to comply with rehabilitation protocols or study follow-ups
* were pregnant females or had other medical conditions which precluded participation.
The Effects Of Toy In Chıldren Durıng Inhaler Therapy

The purpose of the study is to investigate the effect of using a toy that children like during inhaler treatment on children's anxiety and emotional state. In the study, an inhaler treatment will be applied to children with a mask placed on a toy that they like. The purpose of this intervention is to reduce the child's anxiety and increase their emotional adjustment by improving adherence to the treatment.

Respiratory diseases are commonly seen during childhood. Today, inhaler medication is frequently used in the treatment of lower respiratory tract diseases. Inhalation therapy is the process of delivering liquid medication in aerosol form directly to the respiratory tract and lungs using devices called nebulizers. Compared to other treatment methods, the direct delivery of medication to the lungs, the rapid onset of effect, and fewer systemic side effects make inhalation therapy the preferred method for treating children. In treatments administered through inhalation, if the inhalation is being applied for the first time, the child may experience fear and anxiety due to not knowing the procedure. After the nurse explains how the procedure is done, they should use distraction techniques to relax the child and support the effective continuation of the inhalation treatment. Distraction techniques are simple and inexpensive methods, and studies have proven their positive effect on children. This study is designed to investigate the effect of using a toy during inhaler treatment on children's anxiety and emotional state.

Eligibility Criteria:
Inclusion Criteria:

* The child being between the ages of 4 and 6,
* The child being scheduled to receive their first inhaler treatment after admission to the unit,
* No IV or IM interventions being performed before the inhaler treatment,
* The child and parents being willing to participate in the study,
* No mental or neurological disabilities present in the child or parent,
* The child not having any life-threatening illnesses,
* The child having an oxygen saturation of 95% or higher,
* The child's body temperature not exceeding 37.5 degrees Celsius,
* The child's cognitive level and motor development being appropriate for their age,
* The child being able to count up to 10,
* The parent being literate,
* No visual or auditory problems present in the child or parent

Exclusion Criteria:

* The child's general condition (tachycardia, fever, vomiting, etc.) and orientation (disorientation, lethargy, etc.) significantly deteriorating after the inhaler treatment begins,
* The parent or child wanting to withdraw from the study at any stage of the research.
Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).


Eligibility Criteria:
Inclusion Criteria:

* Visual impairment due to choroidal neovascularization (CNV) secondary to PM
* Best corrected visual acuity (BCVA) in the study eye \> 24 and \< 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters
* High myopia (\> -6D), anterior-posterior elongation \> 26 mm; posterior changes compatible with the pathologic myopia
* Either lesion types in the study eye: subfoveal, juxtafoveal, extrafoveal

Exclusion Criteria:

* Patients with uncontrolled systemic or ocular diseases
* Blood pressure \> 150/90 mmHg
* History of pan-retinal, focal/grid laser photocoagulation or intraocular treatment with any anti-VEGF or vPDT in the study eye
* Intravitreal treatment with corticosteroids or intraocular surgery within last 3 months in the study eye

Other protocol-defined inclusion/exclusion criteria may apply
Evaluate the Utility of the ProLung China Test in the Diagnosis of Lung Cancer

A Study to evaluate the utility of the ProLung China Test as an adjunct to CT scan in the diagnosis of lung cancer.

This Study will assess the stability of the ProLung China Test classification algorithm when used as an adjunct to CT scan. This Study will assess whether there are any potential safety concerns of the ProLung China Test when used to evaluate patients with a positive CT scan for lung cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is male or female, age 18 to 80.
2. Subject has undergone CT scan of the lung(s) that indicates one or more nodules or lesions.
3. Subject's pulmonary nodule or lesion is greater than 4mm and smaller than 50mm. Size is determined by the largest nodule or lesion dimension identified from CT imaging.
4. Subject must be able to receive a ProLung China Test within 30 days of abnormal CT within 14 days prior to the tissue biopsy or surgical resection.

Exclusion Criteria:

1. Subject has an implanted electronic device in the chest. Subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis.
2. Subject with diagnosed malignancy other than lung cancer who has 2 or more suspicious pulmonary nodules.
3. Subject has received an invasive medical or surgical procedure within the thoracic cavity within 30 days prior to the ProLung China Test or within the previous 14 days for a bronchoscopic procedure.
4. Subject presents with an anomalous physical or anatomical condition that precludes ProLung China Test measurement.
5. Subject will have undergone unusually strenuous exercise within 24 hours.
6. Subject who has significant systemic diseases such as uncontrolled diabetes, advanced heart failure, or a recent myocardial infarction, or other medical condition such as severe morbid obesity that in the judgment of the Principal Investigator would make him/her unsuitable for the Study.
Efficacy and Safety of Finerenone in Heart Failure With Reduced Ejection Fraction

Finerenone is a new selective nonsteroidal mineral corticoid receptor antagonist (MRA), nowadays it's widely used in type 2 diabetes (T2DM) patients with chronic kidney disease (CKD), the newest trial shows finerenone improve the cardiovascular outcomes among patients with T2DM and CKD especially reduce the risk of hospitalization for heart failure. In patients with diabetic nephropathy, finerenone resulted in lower risks of CKD progression and cardiovascular events. Finerenone shows great potential therapeutic effect in chronic heart failure (CHF) patients with or without T2DM and CKD compared to eplerenone, but there is still no real world study on finerenone in patients with heart failure with reduced ejection fraction (HFrEF) and it's unclear about the effect of finerenone in CHF patients without T2DM and CKD. The investigators will conduct a study to demonstrate the efficacy and safety of finerenone in HFrEF patients compared to other MRAs.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* New York Heart Association(NYHA) functional classification II - IV
* LVEF measured by the echocardiogram ≤ 45%
* eGFR\>25mL/min/1.73m²

Exclusion Criteria:

* LVEF measured by the echocardiogram \> 45%
* History of allergic or hypersensitivity to drugs involved in the trial.
* Patients with a known history of cancer, angioedema, significant congenital heart disease or rheumatic heart disease.
* Patients diagnosed with myocarditis.
* Probable alternative diagnoses could account for the patient's HF symptoms e.g., COPD, bronchial asthma, primary pulmonary hypertension.
* Systolic blood pressure (SBP) ≥180mmHg or diastolic blood pressure (DBP)

  * 120mmHg at visit, DBP≤90mmHg or symptomatic hypotension.
* Patients with cardiac pacemaker
* Pregnant woman
* eGFR≤25mL/min/1.73m² and not accept long-term hemodialysis therapy.
* Serum potassium \>5.2 mmol/l at visit
* Fatal or uncontrollable heart arrythmia e.g., symptomatic or persistence ventricular tachycardia, ventricular rate\>150 bpm in AF patients.
* Obvious stenosis (≥50%) of bilateral renal arteries.
Wald Outreach for Wellness: Blood Pressure Outreach

The Wald Outreach Center will partner with Medicine for the Greater Good (MGG) to implement this pilot project called Wald Outreach for Wellness (WOW), a blood pressure outreach wellness intervention in a retail setting.

WOW aims to provide community members with a digital blood pressure monitor, health education, and health care navigation as practical strategies to improve community members' management of pre-hypertension, and to reduce associated burdens and risks related to hypertension health disparities.

This approach to reaching populations who use retail settings has the potential to implement a health promotion and wellness strategy aimed at populations with increased risk for hypertension related health disparities. The outreach strategy is aimed at reaching community members where community members gather for health care, provide the community members with practical, low-cost strategies for promoting health and wellness, increase community members' knowledge in hypertension management, help the community members navigate health care options and get the community members engaged in a medical home thereby reducing the burdens of hypertension health disparities.

This research is important to continue to assess the best ways to reach and reduce hypertension health disparities in underserved communities with limited access to health care.

Eligibility Criteria:
Inclusion Criteria:

* Community residents who participate in Day at the Market
* Adult individuals 18 years and older whose recorded BP reading is within the pre-hypertensive range 120-139 systolic; 80-89 diastolic
* Able to read and understand English

Exclusion Criteria:

* 17 years or younger
* BP reading above pre-hypertensive range
* Unable to read and understand English
Treatment of Surgical Scars Using the Pulsed Dye Laser

The purpose of this study is to determine whether treatment of fresh surgical scars with a pulsed dye laser using purpura-inducing settings will improve clinical appearance better than one using non-purpura-inducing settings or no treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring Mohs micrographic surgery or excisions for skin cancer or atypical nevi, with an expected post-excision scar of 4.5cm in length or more.
* Willing to participate.
* Able to give informed consent

Exclusion Criteria:

* Location of excision or Mohs surgery on the genitals, hands, or feet.
* Fitzpatrick skin type V or VI.
* Prior history of known light sensitivity.
D-dimer Prognostic Marker of Cerebral Infarction After Revascularization Procedure

Cerebral infarction is the leading cause of acquired disability in adults. Absence of biological marker used in current practice and identified as a prognostic factor for recovery. D-dimers are degradation products of stabilized fibrin translating an activation of coagulation whatever the cause. Studies have shown that increased D-dimer levels in patients with MI is associated with a higher mortality rate, the link with post-intervention non-revascularization has been demonstrate.

The purpose of this project is to search for a correlation between the level of D-dimer and the degree of recovery evaluated by the NIHSS score


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 65
* Cerebral infarctions undergoing a revascularization procedure by thrombolysis and / or thrombectomy, at the Amiens University Hospital between January 2015 and December 2020.
* Patients having benefited from a D-dimer assay (during their stay)

Exclusion Criteria:

-