cyrilzakka/clinical-trials huggingface dataset:
A Trial Comparing the Ischemic Preconditioning Effects of Ticagrelor and Clopidogrel in Humans

Antiplatelet therapy remains a cornerstone in the treatment of acute and chronic coronary artery disease. Aspirin was the first such therapy to prove its benefits in acute myocardial infarction. Compared to aspirin monotherapy, the combination of aspirin and clopidogrel, a thienopyridine P2Y12 inhibitor, has been demonstrated to reduce adverse event rates among patients with acute coronary syndromes (with or without ST-segment elevation) and those receiving intracoronary stents. In the Triton-TIMI 38 trial a novel thienopyridine, prasugrel, was compared to clopidogrel in patients with acute coronary syndrome undergoing percutaneous coronary intervention. Although prasugrel significantly reduced recurrent myocardial infarction, bleeding rates were increased and no improvement in cardiac or all-cause mortality was demonstrated. However, in 2009, the authors of the PLATO trial demonstrated an unexpected cardiovascular mortality benefit with ticagrelor over clopidogrel, an endpoint not previously met by any other antiplatelet agent against an active comparator. Based on the reproducible adverse events seen in the DISPERSE, DISPERSE-2, and PLATO trials, an adenosine-mediated effect of ticagrelor is proposed.

Hypothesis: The aim of this study is to test the hypothesis that ticagrelor produces pharmacologic ischemic preconditioning, an undescribed potential off-label property of ticagrelor that could represent a plausible mechanism for its effects on cardiovascular mortality.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing clinically-indicated PCI for stable or progressive exertional angina without rest angina, ST-segment shift, or elevated CK-MB or troponin-T or I
* Willing and able to give informed consent and to comply with study procedures
* Found to have single or two-vessel obstructive, non-occlusive (≥ 70% but \< 100% stenosis), coronary artery disease with plans for treatment of all lesions by PCI
* Target lesion location in the proximal or mid coronary vessel with reference diameter ≥ 2.5 mm

Exclusion Criteria:

* Known allergy to aspirin, clopidogrel, or ticagrelor
* Need for concomitant cardiac procedure, such as valve repair or replacement
* Age ≥ 75
* Concomitant theophylline/aminophylline use
* Baseline ECG with infarct or conduction abnormalities (i.e. LVH with repolarization abnormality, bundle branch block, ST-segment abnormalities)
* Presenting with an ST-segment elevation or non ST-segment elevation myocardial infarction
* Evidence of prior myocardial infarction by cardiac imaging
* Depressed left ventricular systolic function (ejection fraction \< 50%)
* Clinical congestive heart failure
* End-stage renal disease
* Presence of coronary collaterals on diagnostic coronary angiography
* Presence of coronary thrombus on diagnostic coronary angiography
* Diffuse obstructive disease (≥ 70% stenosis) in the distal segment of the target vessel
* Left main and/or three-vessel coronary artery disease
* Concomitant need for Warfarin therapy
Efficacy of Korean Manupuncture on Pain in Women With Endometriosis: a Parallel-group Randomized Controlled Trial

Endometriosis is defined as the presence and development of hormone-dependent endometrial tissue comprising both glands and stroma outside the endometrium and myometrium.

It affects 10-15% of women of childbearing age; of these, 25% are diagnosed following a consultation for infertility, and 25% following a consultation for pelvic pain.

This disease has a strong functional (pain and infertility) and organic impact, its numerous symptoms can have a considerable effect on quality of life.

Individualized analgesic management with multidisciplinary care (medical, surgical and psychological) can improve quality of life for women with endometriosis, but current treatment remains insufficient.

Korean manupuncture is a complementary treatment technique that does not interact with current treatments. It's a holistic discipline that draws up a highly detailed map of the body's correspondence on the hand. Each body zone corresponds to a zone on the hand.

The aim of this research is to evaluate the effect of Korean manupuncture on endometriosis-related pain.

Patients will be randomly assigned to 2 groups, 30 to the "Korean manupuncture" group and 30 to the "placebo/control" group. Patients will be blinded to their assigned group.


Eligibility Criteria:
Inclusion Criteria:

* Person having given oral consent
* Woman of legal age
* Woman diagnosed with endometriosis consulting for pain management

Exclusion Criteria:

* Not affiliated to the national health insurance system
* Person under legal protection (curatorship, guardianship)
* Person under court order
* Pregnant or breast-feeding women
* Menopausal women (menopause is defined as amenorrhea lasting more than 12 consecutive months)
* An adult unable to give consent
* Women who have had a hysterectomy
* Women who cannot speak or read French
* Hands not accessible for treatment
* Inability to follow the entire protocol
* Cognitive impairment
Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy

The investigators aim to compare the risk of mortality of Non-implantable carioverter defibrillator (ICD) vs. ICD management in patients with heart failure with reduced ejection fraction (HFrEF).

The proposed CONTEMP-ICD trial is a prospective, multicenter, open-label, randomized controlled trial; enrolling 3290 participants with HFrEF, on stable and optimal guideline-directed medical therapy (GDMT), who are eligible for a primary prevention ICD, but have a low predicted arrhythmic risk. Enrolled participants will be randomized in a 1:1 ratio to non-ICD vs. ICD treatment arms. The investigators hypothesize that, in participants with HFrEF who have a low predicted arrhythmic risk, non-ICD vs. ICD is non-inferior with respect to the primary endpoint of all-cause mortality and superior survival free of major cardiovascular (CV) events.

This study will recruit adults 18 years of age and older with heart failure. Participants will be asked to complete questionnaires. Information from medical records will be gathered including medical history, physical exam, medications, blood work results, and imaging. Visits will be at initial, three, six months, and every six months beyond six months. For those who get an ICD device an interrogation will be collected at the visits.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years (no upper limit)
* Class I or IIa indication for a primary prevention ICD15: Ischemic or non-ischemic cardiomyopathy and NYHA Class ≥ II if most recent LVEF is ≤ 35% OR ischemic cardiomyopathy with NYHA Class I if most recent LVEF is ≤ 30%
* Most recent LVEF (%) obtained per cardiac imaging obtained at any time prior to enrollment after being stable on optimal GDMT\*\* for at least one month
* Stable optimal GDMT at least one calendar month prior to last cardiac imaging test, prespecified as one of the following for at least 1 calendar month prior to study randomization:

receiving all 4 therapy classes (beta-blockers, ARNI/ARB/ACE, MRA and SGLT2i) OR GDMT Score ≥ 6 (per Figure 7)

• MADIT-ICD Benefit Score \< 50 (per Figure 4)

Exclusion Criteria:

* Existing ICD/CRT-D
* • Planned CRT-P or CRT-D implant for any indications including Class I or IIa indication for CRT: Presence of left bundle branch block (LBBB) with QRS ≥ 120 msec OR QRS duration ≥ 150 msec regardless of QRS morphology OR decision for CRT implant by EP provider for other indications
* Acute MI within the past 3 calendar months
* Chronic renal failure requiring hemodialysis
* Coronary revascularization within the past 3 calendar months
* History of sustained VT or VF
* Known genetic cause of cardiomyopathy
* Life expectancy \< 1 year
* Unable or unwilling to follow study protocol
* Inability to consent
Effect of Hydroxychloroquine on Atrial Fibrillation Recurrence

Atrial fibrillation is the most common arrhythmia in clinic. It can lead to heart failure or stroke, and has a high disability rate and mortality rate. At present, although radiofrequency ablation can cure atrial fibrillation, the success rate is only 50\~70%, and has a high recurrence rate. In recent decades, no effective new antiarrhythmic drugs have been introduced, but there are side effects in long-term application of the existing antiarrhythmic drugs. Therefore, it is urgent to provide new and effective antiarrhythmic drugs.

Autophagy level of atrial myocytes in atrial fibrillation patients was significantly higher than that in sinus rhythm. Hydrochloroquine (HCQ) is a hydroxychloroquine sulfate composed of 4- amino quinoline compounds. As an effective inhibitor for autophagy, HCQ could effectively prevent the increased autophagy level of atrial myocytes in atrial fibrillation rabbits, prevent atrial effective refractory period (AERP) shortening, and decrease the rate and duration of atrial fibrillation.

At present, hydroxychloroquine is mainly used in the treatment of rheumatic immune system diseases and anti malaria. Because of its good safety and small side effects, HCQ has become an indispensable member of drugs in the combined treatment of rheumatoid arthritis and systemic lupus erythematosus patients. In recent years, studies have reported that hydroxychloroquine plays an important role in the prevention and treatment of cardiovascular diseases. Chloroquine could effectively shorten the action potential of atrial myocytes by blocking the inward rectifier potassium ion channel (Kir2.1) and reducing the inward potassium ion current Ik1. HCQ could also reduce 72% (P=0.002), and 70% for the risk of coronary heart disease, stroke, and transient ischemic disease. So the investigators speculate that HCQ may be a potential drug to block the occurrence of acute atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Successful radiofrequency ablation of atrial fibrillation within 24 hours

Exclusion Criteria:

* History of cerebrovascular disease: ischemic stroke, cerebral haemorrhage and transient ischemic attack.
* History of cardiovascular disease:unstable angina, myocardial infarction, coronary revascularization and congestive heart failure.
* History of renal impairment.
* History of Type I diabetes mellitus or Type II diabetes uncontrolled.
* History of liver impairment.
* History of alcoholism or drug abuse.
* Known severe skin rash or damage.
* Known retinal pigmentation and visual field defect.
* Allergy to any component of hydroxychloroquine.
A Study Comparing Halobetasol Propionate and Tazarotene Topical Lotion 0.01%/0.045% to Duobrii® Lotion (Halobetasol Propionate and Tazarotene Lotion), 0.01%/0.045% (Reference Listed Drug) in the Treatment of Moderate to Severe Plaque Psoriasis.

To evaluate the therapeutic equivalence and safety of halobetasol propionate and tazarotene topical lotion 0.01%/0.045% (Taro Pharmaceuticals U.S.A., Inc.) and Duobrii® Lotion (halobetasol and tazarotene lotion), 0.01%/0.045% (Reference Listed Drug) in the treatment of moderate to severe plaque psoriasis.

A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Halobetasol Propionate and Tazarotene Topical Lotion 0.01%/0.045% (Taro Pharmaceuticals U.S.A., Inc.) and Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045% (Reference Listed Drug) in the Treatment of Moderate to Severe Plaque Psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant female aged ≥ 18 years
* Subjects must have provided IRB approved written informed consent
* Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits
* Subjects with a clinical diagnosis of stable (at least 6 months) plaque psoriasis involving at least 3% and no more than 12% of the body surface area (BSA). Affected areas should not include the axillae, face, scalp, soles, palms, and intertriginous areas

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
* Females of childbearing potential who do not agree to utilize an adequate form of contraception.
* Subjects with a known hypersensitivity to tazarotene, halobetasol propionate, other corticosteroids, or to any ingredients in the study drugs.
* Subjects with current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
Cyanoacrylate Tissue Adhesives Versus Silk Suture at the Palatal Donor Site of Sub Epithelial Connective Tissue Graft

Subepithelial connective tissue grafts (CTG) are considered the gold standard procedure with proven clinical success when it comes to gingival augmentation aims to to improve periodontal health, which can enhance the long-term prognosis of teeth by obtaining soft tissue coverage of exposed root surfaces and/or augmentation the dimensions of gingival tissue. The procedure require harvesting tissue from a the palate, which increases the complexity of the procedure and patient discomfort. Complications after harvesting a graft would be pain, inflammation, bleeding, flap necrosis and infection in the donor site.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mucogingival defects scheduled for sub epithelial connective tissue graft
* Age at least 18 years.
* Not having any systemic disease that could compromise wound healing
* No periodontal surgery on the experimental sites.
* No smoking,
* No pregnancy or lactation

Exclusion Criteria:

* Patients with coagulation disorders
* patients on corticosteroids, with uncontrolled diabetes, or with any systemic disease that precluded periodontal surgery
* patients with a history of contact dermatitis to formaldehyde
* Loss of maxillary premolars and molars
* Medications or antibiotics used in the previous 6 months
* Pregnancy or lactation
* Smoking
Metformin Therapy in Type 1 Diabetes Mellitus.

The use of exogenous insulin and incorrect nutritional habits are conducive to obesity and excess weight. This leads to the development of insulin resistance, even in patients with type 1 diabetes mellitus. The purpose of this study is to assess the effects of metformin as adjunctive therapy on anthropometric parameters, insulin resistance and metabolic control in overweight and obese patients with type 1 diabetes mellitus.

The study group consists of 200 Caucasian type 1 diabetic patients with elevated adipose tissue content as measured by electrical bioimpedance, treated at the Poznan University of Medical Sciences Department of Diabetology in 2009-2014. All patients have type 1 diabetes diagnosed by autoimmune antibodies, and are treated with intensive insulin therapy. This group is divided into metformin treated arm (group I+ M, 100 subjects), the remaining 100 patients are treated with insulin alone (control group, group I). Metformin is administered at least 6 months at a mean dose of 1000 mg/day.

The investigators would like to assess the impact of metformin treatment on metabolic control, insulin resistance and anthropometric parameters in overweight and obese patients with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years \<60 years,
* duration of diabetes \>3 years,
* lack of metabolic control- HbA1C\>7,5% (despite participation in 5-day WHO education program)
* treated with intensive insulin therapy

Exclusion Criteria:

* metabolically decompensate diabetes with acetonuria,
* suspected lack of compliance,
* lack of glucose and ketones self-monitoring,
* hypoglycaemic unawareness or recurrent severe hypoglycemia (defined as more than two episodes of hypoglycemia lowered than 60 mg/dl with loss of consciousness, required assistance to treat) in the past 3 months,
* recurrent diabetic ketoacidosis (more than two episodes in the past year)
* another serious medical illness,
* pregnancy or sexually active woman unwilling to take birth control.
* renal impairment (estimated on the value calculated glomerular filtration rate using the MDRD formula-estimated glomerular filtration rate, eGFR\<45 mL / min
* liver cell damage Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) greater than twice the upper normal limit),
* history of drug or alcohol abuse or those who used this drug before
* changes in the way of antihypertensive and antihyperlipemic treatment.
Monitoring of Piperacillin-Tazobactam and Meropenem Plasmatic Levels in Critical Patients

The aim of this study is to establish the Piperacillin-Tazobactam and Meropenem Plasmatic Levels to know if it´s necessary to make some adjustment in the recommended dose regimen.


Eligibility Criteria:
Inclusion Criteria:

* Patients above 18 years old.
* Hospitalized in the Intense Care Unit.
* Patients treated with Piperacillin-Tazobactam or Meropenem.
* Septic shock.
* Renal hyper clearance.
* Gram-negative bacillary bacteremia.
* Continuous renal replacement technique.
* ECMO.
* Obesity (BMI\> 40).

Exclusion Criteria:

* Patients under 18 years old.
* Pregnant women.
Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention

This study will evaluate an oil blend with active ingredients for the reduction in chemotherapy-induced peripheral neuropathy in people with breast cancer. Half of the participants will receive the oil blend with active ingredients and the other half will receive a placebo (an oil blend with no active ingredients). One-fourth of the people will also take pictures of their life with chemotherapy-induced peripheral neuropathy.

Chemotherapy-induced peripheral neuropathy (CIPN) is a painful, debilitating consequence of cancer treatment and is considered the most adverse of non-hematologic events. Current pharmacological approaches to reduce CIPN symptoms can be ineffective and cause adverse effects.

Constituents of this oil blend moderate pain signal transmission through non-competing inhibition of 5-HT, AchE, and Substance P, along with antagonism of TRPA1 and TRPV1. This study will test the hypothesis that an oil blend reduces CIPN symptoms and improves quality-of-life (QOL) in breast cancer patients. The Human Response to Illness model is used to underpin a convergent-nested-parallel mixed-methods design with intervention.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of breast cancer
* chronic CIPN symptoms in one or both lower extremities
* three months or greater since last chemotherapy treatment
* mean SF-MPQ-2 score of greater than or equal to three
* a prognosis of greater than six months

Exclusion Criteria:

* non-English-speaking
* blindness
* pregnancy
* breastfeeding
* allergy to EOI or Peru balsam (cross-allergen)
* illegal substance usage
* history of severe skin reactions
* non-intact skin on lower extremities
* history of lower extremity trauma or amputation
* current use of aromatherapy/Essential Oils
* asthma or reactive airway disease triggered by constituents of EOI
* history of mental illness or chronic depression
* the following co-morbidities: G6PD deficiency, inherited peripheral neuropathy, active herpes varicella-zoster, herpes simplex virus, alcoholic neuropathy, repetitive stress or entrapment neuropathy, peripheral vascular disease, and multifocal mononeuropathy.
Evaluation of Exercise Treadmill Test (ETT) Indices in Participants With Cardiovascular Disease

The study was designed to evaluate the use of ETT electrocardiogram (ECG) indices as biomarkers in the assessment of atherosclerotic coronary vascular disease (ASCVD).


Eligibility Criteria:
Inclusion Criteria:

* History of stable coronary artery disease

Exclusion Criteria:

* Inability or unwillingness to participate in multiple exercise treadmill tests and/or any other requirements of this study as assessed by the Investigator.

  * History of chronic atrial fibrillation.

Other protocol-defined inclusion/exclusion criteria may apply.
Evaluation of Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation.

This study is a 5 day, single-center, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of Somatostatin used as inflow modulator in liver transplantation. Patient systemic and hepatic dynamics will be collected and recorded at predefined time-points. To evaluate the ischemia-reperfusion injury, it is planned to perform liver biopsies at two different time-points to compare the liver structure and proteomic variations.


Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness to provide written informed consent
* Cirrhotic patients with established clinically significant portal hypertension (CSPH) defined as an increase in hepatic venous pressure gradient \>= 10 mmHg
* Recipients who are 18-70 years of age receiving a primary liver transplant from a brain dead donor or living donor
* Whole liver grafts and partial liver grafts can be included

Exclusion Criteria:

* Patients who are recipients of multiple solid organ transplants, or have previously received an organ or tissue transplant that may not be completely resolved by thrombectomy
* HIV positive patients
* Patients with known history of portal thrombosis or diagnosed at the time of transplantation that may not be completely resolved by thrombectomy.
* Patients included in the preoperative assessment without a CSPH at the time of the first intraoperative measurement of portal pressure
* Patients with low portal perfusion (=\< 90 ml/min\*100 g of LV) measured at the time of operation. Portal flows above this limit can be excluded in the eventuality that, after infusion, the portal perfusion falls below this limit
* Patients with porto-pulmonary hypertension
* Patients with known cardiac arrhythmias
* Recipients of cardiac-dead donors
* Fulminant hepatic failure patients
Selection Criteria in Endovascular Thrombectomy and Thrombolytic Therapy (SECRET) Study: Development of Patient Selection Criteria Using CT Images and Accompanying Diseases for Efficient Intravenous Thrombolytic and Intra-arterial Recanalization Therapy in Acute Ischemic Stroke

Use of intravenous (IV) thrombolysis and intra-arterial (IA) recanalization treatment has been rapidly increasing, However, despite of the treatment, recanalization rates are 22.6 - 70% and only 30-50% of patients show meaningful clinical improvements. Mechanisms of futile recanalization may include 1) large ischemic core, 2) poor collateral, and 3) presence of comorbidity. In this regards, developing selection criteria using acute stroke imaging and comorbidity is warranted.

Investigators will recruit the consecutive acute stroke patients who received IV thrombolysis and/or IA recanalization treatment. This study will perform with prospective design to develop CT-based clot, core and collateral scores and a comorbidity index for selecting stroke patients who are at high risks by the treatment. Investigators will firstly establish the CT-based scores and comorbidity index using a pre-existing cohort database. Using these CT-based and comorbidity index, Investigators will validate them in a multi-center prospectively cohort. In addition, Investigators will assess the cost-effectiveness of selecting patients based on the comorbidity index.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥20 years old
* Acute ischemic stroke patients who underwent CT angiographies before IV thrombolysis and/or IA recanalization treatment
* Patients who give an informed consents for participation in the study or the legal representative or immediate family give informed consent on behalf of patients in case of difficulty to decide study enrollment.

Exclusion Criteria:

* Age \<20 years old
* Acute ischemic stroke patients who did not receive IV thrombolysis and/or IA recanalization treatment
* No informed consents from patients