cyrilzakka/clinical-trials huggingface dataset:
Get With The Guidelines-Heart Failure Registry

Get With The Guidelines-Heart Failure is designed to improve the quality of care in patients hospitalized with heart failure. The program aims to help ensure that eligible patients are initiated on guideline recommended therapies and receive appropriate counseling prior to hospital discharge.

Get With The Guidelines-Heart Failure was initiated in 2005 with over 500 U.S. hospitals participating is designed to improve the quality of care in patients hospitalized with heart failure. The program aims to help ensure that eligible patients are initiated on guideline recommended therapies and receive appropriate counseling prior to hospital discharge.

Peer-reviewed research(with over 35 manuscripts) has demonstrated that through participating in Get With The Guidelines-Heart Failure, hospitals will provide equitable care (regardless of race, ethnicity, age, or gender), the importance of scheduled physician follow-up after heart failure hospital discharge, the value in device-support as necessary for the acute heart failure patient, and many other significant findings.

Achievement measures tracked through Get With The Guidelines-Heart Failure:

* Angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) at discharge
* Evidence-based specific beta blockers
* Measure left ventricular function
* Post-discharge appointment for heart failure patients

Quality Measures tracked through Get With The Guidelines-Heart Failure:

* Mineralocorticoid receptor antagonist at discharge
* Aldosterone antagonist at discharge
* Anticoagulation for atrial fibrillation
* Hydralazine nitrate at discharge
* DVT prophylaxis
* CRT-D or CRT-P placed or prescribed at discharge
* ICD counseling, or ICD placed or prescribed at discharge
* Influenza vaccination during flu season
* Pneumococcal vaccination
* Follow-up visit within 7 days or less
* Lab monitoring follow-up
* SGLT-2 inhibitor at discharge
* Defect-free care for quadruple therapy medication for patients with heart failure with reduced ejection fraction
* Direct-acting oral anticoagulant at discharge for non-valvular atrial fibrillation or atrial flutter patients

Additional measures collected by Get With The Guidelines-Heart Failure can be viewed at: http://www.heart.org/idc/groups/heart-public/@wcm/@private/@hcm/@gwtg/documents/downloadable/ucm_310967.pdf

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized with congestive heart failure.

Exclusion Criteria:

* Patients who do not have congestive heart failure,
* Patients under age of 18,
* Patients not admitted as inpatients.
The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage

The purpose of the study is to compare the clinical effectiveness of gingival unit graft (GUG) and connective tissues graft (CTG) in Miller's class I and II gingival recession.

Patients who accept the study have provided information about the study and required a written informed consent form. The clinical effectiveness of two different periodontal surgical techniques (gingival unit graft and connective tissue graft) in gingival recessions will be evaluated. Periodontal measurements (gingival recession, keratinized gingiva height) and patient-reported outcomes (intra and post-operative pain, patient satisfaction and hypersensitivity) are defined.

Eligibility Criteria:
Inclusion Criteria:

* Systemic healthy individuals
* Presence Miller's class I and II gingival recession in the anterior and premolar teeth

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Lactation
* Any cardiovascular, renal or hepatic conditions
* History of periodontal surgery
* Tooth mobility
* Presence of probing depth \>3 mm and caries or restorations in the teeth undergoing treatment
Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial

The FARGO trial is a prospective, randomized (1:1), multicenter study. The aim of the study is to assess the importance of fractional flow reserve (FFR) assessment prior to coronary artery bypass grafting (CABG) with respect to planning and guiding the revascularization strategy. The study compares an FFR-guided strategy to an angiography-guided strategy in patients planned for surgical revascularization.

FFR measurements are made on all patients that enters the study. FFR measurements on coronary arteries with intermediate stenoses, that are planned for grafting, are done before CABG is performed. Patients are randomized to either an FFR-guided CABG or an Angiography guided CABG.

Eligibility Criteria:
Inclusion Criteria:

* Stable angina or unstable angina / NSTEMI (Non ST segment elevation myocardial infarction) candidate to CABG
* At least one study lesion, which is an intermediate lesion planned for grafting at the Heart Team Meeting.(Definition of Study lesions: ≥ 50% stenosis of a major epicardiel artery (where the proximal reference segment has a diameter\> 2.5 mm), which can be passed with a FFR-wire without significant risk. Study Lesions can be drawn from all coronary arteries.)
* Signed informed consent form

Exclusion Criteria:

* Significant valvular disease with indication to surgical treatment
* Previous open-heart-surgery
* Left main lesion without other intermediate lesions
* Treatment with Persantin Retard
* One vessel disease
* Renal impairment (creatinine ≥ 150 umol / l)
Urea Cream Treatment Sorafenib-Associated HSFR in HCC

Although sorafenib is effective and safe in patients with advanced hepatocellular carcinoma (HCC), it increases dermatologic toxicities, including hand-foot skin reaction (HFSR), which may have a negative impact on patient quality of life (QoL). Urea-based creams may have a prophylactic effect on sorafenib-induced HFSR in HCC patients.

Mild hyperkeratosis is an early sign of HFSR and may sometimes be the only manifestation of sorafenib-associated HFSR. Urea is useful for the treatment of hyperkeratotic conditions and has been recommended for the treatment of multitargeted kinase inhibitor-related HFSR . To our knowledge, no randomized, controlled trials to date have evaluated treatments to prevent/palliate sorafenib-associated HFSR. We therefore tested the prophylactic effects of a urea-based cream on the incidence of HFSR associated with sorafenib treatment of patients with advanced HCC.

Eligibility Criteria:
Inclusion Criteria:

* The patients with hepatocellular carcinoma will receive sorafenib per instructions of the package insert
* The patients with hepatocellular carcinoma must be willing to participate in this study and provide the investigators with written consents;
* The patients must be willing and able to complete the biweekly visits for the first 3 months;
* The patients must be willing and able to fill in the patient's efficacy questionnaires. If the patients cannot use pens or pencils, the patient's acquaintances or the clinical staffs will complete these questionnaires based on the answers provided by the patients
* The patients must discontinue all prior cancer treatment in at least 3 weeks before enrollment;
* The patient's life expectancy is ≥3 months
* The patients must provide written informed consents

Exclusion Criteria:

* The patients participated in other clinical trials
* The patients received sorafenib therapy prior to enrollment
* The patients combined other treatment or used other biological therapy, chemotherapy, experimental treatment or radiotherapy
* The patient's sorafenib dosage exceeds 400mg, twice daily
Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL)

The purpose of this research study is to evaluate how effective ONTAK is in the treatment of cutaneous T-cell Lymphoma (CTCL) and determine whether the presence of a type of protein called CD25 on the cancer cells makes a difference in how the body responds to the treatment.

The hypothesis is that there is no difference in response rate for patients whose tumor cells are CD25 positive or negative.


Eligibility Criteria:
Inclusion Criteria:

* Persistent or recurrent cutaneous T-cell lymphoma (CTCL) Stage IB-IVA as defined by TNM staging.
* Pathologic proven diagnosis (cytologically confirmed) of CTCL documented in patient history.
* Preserved organ function: Creatinine and/or Liver Function levels \<1.5 times institutional upper limits of normal (ULN).
* Adequate liver function as indicated by bilirubin \< or equal to 1.5 times ULN, ALT \< or equal to 2 times ULN, AST \< or equal to 2 times ULN.
* Albumin \>3.0 g/dL
* Adequate renal function as indicated by SCr \< or equal to 2.5 mg/dl.
* ECOG performance status between 0-2.
* Women of childbearing potential should be screened for pregnancy prior to treatment and utilize effective contraceptive methods (e.g. barrier) during treatment period.
* Patients over the age of 18 who are willing and able to provide Informed Consent.

Exclusion Criteria:

* Pathology consistent with peripheral T-cell lymphoma.
* Stage IVB (visceral involvement with CTCL, other than lymph node involvement).
* History of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infection.
* Patients who are pregnant or breast feeding.
* Allergy to or have history of allergy to diphtheria toxin or IL-2.
* Previous ONTAK® usage.
* Unstable cardiovascular disease.
* Patients who have received systemic or topical antineoplastic therapy or investigational medications within past 14 days. Exception: Clear evidence of disease progression requiring immediate intervention and in the absence of ongoing toxicity from prior therapy.
* Ongoing deep vein thrombosis or a diagnosis of deep vein thrombosis less than 3 months prior to protocol enrollment.
Comparison of the Substitution Between Different Tobacco/Nicotine Products as a Function of Tobacco-user Type

This study will investigate the relative appeal (abuse liability) of novel tobacco products, how the appeal is modulated by relative price, user type, and how novel products may substitute for one another.

An important aim of tobacco control is to reduce demand for the most harmful products. Therefore, a priori knowledge of substitutability across novel and widely used tobacco products may forecast the impact of policies on product switching. This study will use a novel method, the Experimental Tobacco Marketplace (ETM), to characterize the relative substitutability and appeal (abuse liability) of tobacco products (e.g., conventional cigarettes, nicotine vaping products \[NVP\], heated tobacco products \[HTP\], and nicotine pouch products \[NPP\]), and how the appeal is modulated by relative price and user type. Exclusive cigarette smokers and dual cigarette/NVP users, stratified by age, will complete multiple scenarios in the ETM.

Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent
* Be at least 21 years of age or older
* Provide a breath sample for measuring carbon monoxide (CO ≥ 8 ppm)
* Stable tobacco use patterns for at least three months
* Be willing to sample NVPs, HTPs, and NPPs
* For exclusive cigarette smokers: smoke at least 10 cigarettes daily and do not use NVPs regularly (no more than 9 times in the last month)
* For dual cigarette/NVP users: smoke at least 5 cigarettes daily and use NVPs for at least 3 times in a week (report use of closed nicotine salt system)

Exclusion Criteria:

* Have plans to move out of the area
* Have a serious or unstable physical or mental health condition
* Taking a tobacco cessation medication or medication that interferes with nicotine metabolism, motivation or reinforcement
* Report concrete, immediate plans to alter/quit using their usual nicotine products at the beginning of the study
Efficacy and Safety Evaluation of the Imescard Compound Water Smartweed Ointment

The aim of our study was to assess the clinical efficacy and safety of the drug Imescard compound water smartweed, adrenalin and hamamelis ointment in the treatment of hemorrhoidal disease in adults, in a randomized, double-blind, placebo-controlled clinical trial.

The drug Imescard compound water smartweed ointment is currently registered at the brazilian National Sanitary Surveillance Agency (ANVISA) as a topic hemorrhoidal treatment. It's composed by adrenalin, which produces vasoconstriction, benzocaine, an anesthetic, hamamelis, which is believed to have a desiccative and astringent activity, and water smartweed (Polygonum hydropiperoides), commonly used in the treatment of this condition, with, however, little or no evidence other than tradition to support its use. The aim of this study was to assess the clinical efficacy and safety of this drug in the treatment of hemorrhoidal disease in adults, in a randomized, double-blind, placebo-controlled clinical trial.

Sixty healthy volunteers with ages between 18 to 70 years old who presented with 2nd to 4th degree hemorrhoids were enrolled after clinical and laboratory evaluation (day 0) and then randomized (day 1) to receive either the Imescard ointment after waking up, after evacuations and before bedtime, for 5 days, or placebo, with the exact same appearance and posology. At followup (day 8), patients underwent new clinical and laboratory evaluation. Main outcome was the percentage of patients with 50% improval of symptoms, assessed by a diary containing symptom questionnaires concerning every day of treatment. Secondary outcomes were mean scores of the symptom questionnaires, life quality improval assessed by WHOQOLbrief at days 1 and 8 and adverse effects evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years old
* 2nd to 4th degree hemorrhoids clinically diagnosed
* Proper anticonception, in the case of women in fertile age
* Possibility to abstain from any other drugs (except in emergencies, in wich case the responsible party must be informed)
* Good understanding and agreement to informed consent form

Exclusion Criteria:

* Hypersensitivity to any of the components of the drug
* Use of alcohol or drugs
* Clinical evidence of immunosupression
* Abnormalities in baseline laboratory exams
* Diagnosis of any acute disease in current activity or chronic disease uncontrolled
To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma

This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia.


Eligibility Criteria:
Inclusion Criteria:

* Agreement to avoid pregnancy or fathering children.
* Participants who are transfusion-dependent or present with symptomatic anemia

For MDS participants:

* Ineligible to receive or have not responded to available therapies for anemia such as ESAs or lenalidomide.
* Not requiring cytoreductive therapy other than hydroxyurea.
* BM and peripheral blood myeloblast count \< 10%.
* Histologically confirmed diagnosis of the MDS, CMML and unclassifiable MDS/MPN overlap syndromes.

For MM participants:

* Histologically confirmed diagnosis of MM.
* After failure of available standard treatments such as alkylating agents, glucocorticoids, immunomodulatory drugs (lenalidomide,pomalidomide, or thalidomide), proteasome inhibitors (bortezomib or carfilzomib), and daratumumab.

Exclusion Criteria:

* Any prior allogeneic stem cell transplantation or a candidate for such transplantation.
* Any major surgery within 28 days before the first dose of study drug.
* Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, or antibody or hypomethylating agent to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.
* Undergoing treatment with another investigational medication or having been treated with an investigational medication within 28 days before the first dose of study drug. -Undergoing treatment with ESAs, granulocyte colony-stimulating factor or granulocyte/macrophage colony-stimulating factor, romiplostin, or eltrombopag at any time within 28 days before the first dose of study drug.
* Undergoing treatment with a strong or potent inhibitor or inducer of CYP3A4/5 within 28 days or 5 half-lives (whichever is longer) before the first dose of study drug or expected to receive such treatment during the study.
* History of clinically significant or uncontrolled cardiac disease.
* History or presence of an abnormal ECG that, in the investigator's opinion, is clinically Meaningful.
* Presence of chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
* Diagnosis of chronic liver disease.
In Vivo Study of Sucrose and Liquid Oral Pediatric Medicines of Long-term Effect on Dental Biofilm pH

The aims of this study were to determine the sucrose and liquid oral pediatric medicines of long-term effect on dental biofilm pH to evaluate the cariogenic potential in vivo.

Te study was carried out with 12 subjects that were refrained from brushing their teeth for 28 h and did not eat or drink for at least 3 h prior to each appointment. Dental biofilm pH was measured in the cervical and proximal regions of anterior teeth with beetrode-type microelectrode coupled to a potentiometer. The biofilm was submitted nine paediatric medicines a long term and sucrose (negative control). pH measurements were taken at baseline to determine resting plaque pH and at time interval 5, 10, 15, 20, 25 and 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 22 years;
* Having Oral hygiene adequate (OHI\<1.1);
* Having 20 natural teeth incluing molar;
* Not havind oral disease.

Exclusion Criteria:

* Biofilm baseline pH \> 5,5;
* Not signature consent term;
* Using orthodontic appliance;
* Having used medicines last 3 months;
* Pregant woman.
Safety and Efficacy of EXO-CD24 in Preventing Clinical Deterioration in Patients With Mild-Moderate ARDS

This is phase IIb, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 of one dose 10\^10 exosome particles, to Prevent Clinical Deterioration in Patients with Mild-Moderate ARDS

The study population will include patients with mild-moderate ARDS and laboratory markers predictive of the cytokine storm, who have provided an informed consent.

90 patients will be initially screened, randomized and stratified by center in a 2:1 ratio to receive either 1010 exosome particles (60 patients) or placebo (30 patients).

Study drug will be delivered using standard jet nebulizer that produce aerosol particles size of 0.4-4.4 µm.

The exosomes will be diluted in 1.5 ml normal saline for inhalation, administered twice a day (bid) for 5 days

Study treatments will be given as an add-on to the standard of care. Following the 5 days of treatment, patients will remain in follow-up for 23 additional days. In case of hospital discharge before the full follow-up planned, the patient will be required to return to the site for completion of all study assessments.

Eligibility Criteria:
Inclusion Criteria:

1. Direct and indirect lung injury etiology
2. Age ≥18 years
3. Patients with Early Acute Lung Injury (EALI) \> 2 ,or patient on HFNC/NIPPV \[(1 point for an oxygen requirement \> 2 to 6 liters/min or 2 points for \> 6 liters/min; 1 point each for a respiratory rate ≥ 30 breaths/min and baseline immune suppression) (immune system compromised by exogenous drug etc.)\] (For saturation goal \>90%) \[1\], or ARDS diagnosis (mild/moderate)
4. Willing and able to sign an informed consent, or has a legal guardian who is able to sign

Exclusion Criteria:

1. Any concomitant illness that, based on the judgment of the investigator might affect the interpretation or the results of the study (immunodeficiency, primary immune deficiency due to virus, hematological malignancy etc.)
2. Patients with SaO2/FiO2\<150
3. Patients with mechanical ventilation (ECMO).
4. Pregnancy \[positive urine pregnancy test (women of childbearing potential only)\] or breastfeeding
5. Participation in any other interventional study in the last 30 days or within 5 half-lives of receiving an investigational agent.
The Effect of Transcranial Direct Current Stimulation on Fatigue Among Multiple Sclerosis Patients.Patients

This work is aimed to assess the long term effect of TDCS in fatigue management among MS patients

Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system that is considered one of the most frequent causes of disability in the young adult.

Fatigue in MS may affect up to 80 % of the people with MS. It tends to persist over time once it appears. However, despite high frequency, fatigue remains poorly understood. Fatigue in MS is neither consistently linked to disease severity nor disease duration, although it is found to be worse in individuals with the secondary progressive subtype.

Fatigue is distinct from sleepiness, and fails to improve with adequate sleep. Multiple factors are thought to contribute to fatigue\[7 , 8\] with no specific biomarker or etiology yet confirmed.

A wide variety of therapies have been tested to reduce fatigue in MS, but unfortunately, none have been consistently effective. Transcranial direct current stimulation (tDCS) is a relatively recent therapeutic development that utilizes low-amplitude direct currents to induce changes in cortical excitability. Although various non-invasive neuromodulation technologies are available , tDCS has unique advantages compared to other stimulation methods such as its ease of use, lower cost, and greater safety and tolerability.

Small preliminary studies have observed that tDCS may be a promising treatment for MS fatigue, using sham-controlled crossover designs, with five tDCS sessions, using either a motor, sensory, or dorsolateral prefrontal cortex (DLPFC). Recently Chalah et al.\[12\] study demonstrated that DLPFC (left anodal) when compared the posterior parietal cortex led to the most fatigue specific improvements.

Thus, tDCS can reduce fatigue burden for people with MS, it may be possible to implement a tDCS therapy for symptomatic management of fatigue.

Eligibility Criteria:
Inclusion Criteria:

Any adult patient will be fulfilling diagnostic criteria of Multiple sclerosis and could be providing consent for participation in the study, will be included in the study.

Exclusion Criteria:

* any patient showed this following condition will be excluded from the study;
* Any MS patient had any contraindication condition to use TMS or TCDS (such as epilepsy, head trauma, metallic procedure, cerebral insult)
* Any patient had infection or febrile condition.
* Any patient had other co morbid neurological or psychiatric disorders or systemic disease.
* Any patient refuses participation in study.