cyrilzakka/clinical-trials huggingface dataset:
Colchicine for the Reduction of Dependency and Vascular Events After an Acute Intracerebral Hemorrhage

Data indicate that patients with intracerebral hemorrhage (ICH) are at high risk for thromboembolic events and disability that is not being sufficiently mitigated by current treatment strategies. This is aggravated by the cessation of antithrombotic medications for significant periods after hemorrhage. These findings highlight the need for novel treatments that modify the high risk for major vascular events and functional outcomes in ICH survivors.

The objective of CoVasc-ICH 2 is to demonstrate that oral colchicine 0.5 mg daily is superior to placebo for improving the outcomes of ICH survivors with evidence or risk factors for atherosclerosis, when started within 72 hours from ICH onset.


Eligibility Criteria:
Inclusion Criteria:

Adult patients presenting with spontaneous intraparenchymal hemorrhage within 72 hours of symptom onset and qualifying for at least one of the following categories:

i. history of symptomatic coronary, peripheral and/or carotid artery disease (severe atherosclerotic vascular disease), or ii. visualized extracranial cervical/intracranial atherosclerotic disease causing any degree of stenosis/occlusion or presence of aortic arch plaque with maximum thickness ≥1 mm (moderate atherosclerotic vascular disease), or iii. two or more risk factors including: age 60 years or older, hypertension, dyslipidemia, diabetes mellitus, chronic kidney disease (eGFR: 15-50mL/min), history of ischemic stroke or current smoking (mild atherosclerotic vascular disease).

Exclusion Criteria:

* secondary causes of ICH (such as trauma, macrovascular anomalies, neoplasms or bleeding diathesis)
* ICH volume more than 60ml in the last imaging scan prior to consent
* Glasgow Coma Scale (GCS) score less than 7 or being intubated at the time of consent
* inflammatory bowel disease or chronic diarrhea
* cirrhosis or severe hepatic dysfunction
* renal insufficiency (eGFR\<15mL/min)
* concurrent or planned treatment with strong CYP3A4 inhibitors (atazanavir, clarithromycin, darunavir/ritonavir, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, tipranavir/ritonavir) or P-gp inhibitors (cyclosporine, ranolazine)
* pregnancy or breast-feeding
* known allergy or sensitivity to colchicine
* a strong indication for colchicine where assignment to placebo is deemed unacceptable
* estimated life expectancy less than 6 months at the time of enrollment, and
* inability to adhere to study procedures
Postoperative Outcomes and Patient Satisfaction With Mayo Clinic Florida Care Hotel After Mastectomy and Tissue Expander Placement

This study evaluates the postoperative outcomes of patients who are admitted to the Mayo Clinic Florida Care Hotel after mastectomy and tissue expander placement. At Mayo Clinic Florida, patients receiving low risk surgeries are often admitted to the hospital overnight for observation. A new model of delivering patient care was created at the Mayo Clinic Florida coined the "Care Hotel." This is a temporal, voluntary accommodation that offers patients a comfortable environment to receive nursing care before or after hospital treatment with in-person daytime monitoring and 24-hour virtual tele-monitoring in a hotel setting. This study evaluates post operative complications in patients who underwent mastectomy followed by tissue expander reconstruction and were admitted to the Care Hotel for overnight observation compared to the standard hospital admission and those who are discharged home.

PRIMARY OBJECTIVE:

I. To investigate post operative complications in patients who underwent mastectomy followed by tissue expander reconstruction and were admitted to the Care Hotel for overnight observation compared to the standard hospital admission and those who are discharged home.

OUTLINE: This is an observational study.

Patients have their medical records reviewed and may complete a survey on study.

Eligibility Criteria:
Inclusion Criteria:

* Women who underwent mastectomy followed by tissue expander reconstruction for breast cancer or high-risk gene mutation prophylaxis followed by immediate tissue expander reconstruction who are either admitted to the Care Hotel post operatively, discharge home or admitted to the hospital.

Exclusion Criteria:

* Younger than 18 years old.
PRESTIGE: PREvention of Stent Thrombosis by an Interdisciplinary Global European Effort

The PRESTIGE-registry is a joint effort at 9 European heart centers to collect data regarding patients presenting with stent thrombosis in a dedicated database. There will be extensive clinical and procedural characterization, furthermore blood platelet function testing, intracoronary imaging, DNA-sampling and analysis of thrombus aspiration will be performed.

Rationale: Stent Thrombosis (ST) is a serious complication of percutaneous coronary intervention (PCI) with stent implantation. Previous studies have been hampered by small sample size, in particular regarding the number of patients with late and very late ST and patients with DES thrombosis, and by incomplete patient characterisation, particularly concerning intracoronary imaging and blood platelet function data.

Objective: to identify novel predictors and to observe clinical outcome after an episode of ST, with the use of state-of-the-art new techniques such as OCT/IVUS, platelet function testing, genetic analysis.

Study design: multicenter matched case control study

Study population:

Cases: all patients presenting with definite ST. Expected number of patients to be included: 2000

Controls: patients undergoing PCI will be matched based on the following criteria:

Expected number of patients to be matched: 2000

1. who underwent a PCI for the same indication
2. who underwent a PCI on the same date (±5 days)
3. who underwent a PCI in the same interventional centre Main study parameters/endpoints: clinical, ECG, biochemical, angiographic, procedural, haematological, histopathological, genetic, OCT/IVUS-imaging, and follow-up characteristics Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Prior to PCI, 50 ml of whole blood will be drawn from all patients. Primary PCI for ST will be performed according to institutional best practise. During PCI, performance of Optical Coherence Tomography and/or Intravascular Ultrasound is encouraged. Thrombus aspiration is performed when indicated. During hospitalisation, all patients will be asked to fulfil a questionnaire regarding possible triggering mechanisms that might have provoked the ST. Patients will be asked to visit the patient clinic for platelet function 30 days after the acute phase of the ST. Finally, patients will be contacted for follow-up details.

Eligibility Criteria:
Inclusion Criteria:

* patients presenting with stent thrombosis

Exclusion Criteria:

* patients refusing informed consent
Pilot/Pivotal Study of DBS+Rehab After Stroke

The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.

The RESTORE Stroke Study combines two phases of study under one protocol (pilot/pivotal). The first phase has a sample size of 40 subjects. The second phase has an estimated sample size of 162 subjects which may be adjusted based on analysis of the first phase.

Each subject will be implanted with the DBS system, undergo DBS program optimization, and be randomized to test treatment (Tt) or active-control treatment (Ct). After randomization, all subjects will participate in a five-month outpatient rehabilitation therapy program. After five months of blinded randomized testing, subjects assigned to active-control treatment (Ct) will cross over to receive test treatment (Tt) and participate in a second five-month therapy program.

Eligibility Criteria:
Key Inclusion Criteria:

* Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis.

Key Exclusion Criteria:

* Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment
* Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus
Registry of Secondary Revascularization

The study will evaluate patients with, at least, one previous procedure of coronary revascularization (surgical, percutaneous or both), that are referred for a new, clinically indicated, diagnostic coronary angiography, to describe their clinical characteristics, management, and prognosis, and will propose a prognosis-oriented classification.

Secondary or repeated revascularization refers to any repeated coronary intervention following an index coronary revascularization procedure, and represents a wide proportion of patients received in catheterization laboratories. These patients have an increased complexity and worse outcomes than patients without previous revascularization. Clinical investigation has focused in lesion-specific treatments when a single previous revascularization fails, but there is paucity of patient-level information including complex patients with multiple revascularizations. Other gaps in evidence addressed by this study are the absence of a a prognosis-oriented classification of previously revascularized patients and a clinical meaningful definition of revascularization failure. The registry as well intends to provide insights on how secondary revascularization decisions are taken and long term prognosis after secondary revascularization.

The registry of secondary revascularization (in Spanish: Registro multicéntrico de reVAscularización SECundaria, REVASEC) is a multicenter, prospective, observational cohort study that incudes consecutive patients with at least one previous coronary revascularization undergoing a clinically indicated diagnostic coronary angiography, in different Spanish hospitals. The aims are describing the incidence, clinical profile, therapeutic management and prognosis of these patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Previous successful coronary revascularization, either percutaneous or surgical, in at least one vessel with diameter ≥2 mm
* Previous successful coronary revascularization must have been successful in at least one vessel and the patient must have been discharged after the previous revascularization
* Clinically indicated diagnostic coronary angiography
* Provide written informed consent

Exclusion Criteria:

* Inability or refusal to provide written informed consent
* Patient included in any other clinical trial in which the revascularization device is blind to patient or investigator, or is not commercially available
* Insufficient data about previous revascularizations
* Previous revascularization only on vessels of less than 2 mm or which was not successful in any vessel
* Previous percutaneous revascularization with simple plain old balloon angioplasty
* Index coronary angiography indicated as scheduled repeated angiography, planned percutaneous coronary intervention, or pre-surgical angiography
Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)

The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy


Eligibility Criteria:
Inclusion Criteria:

* Men \& women ≥18 years of age
* Histologic confirmation of renal cell carcinoma (RCC) with clear-cell component
* Advanced/metastatic RCC
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
* Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting
* No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within 6 months of enrollment
* Karnofsky Performance Score ≥70%

Exclusion Criteria:

* Any Central Nervous System (CNS) metastases or history of CNS metastases
* Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor
* Any active known or suspected autoimmune disease
* Uncontrolled adrenal insufficiency
* Active chronic liver disease
* Prior malignancy active within past 3 years, except for locally curable cancers

Other protocol-defined inclusion/exclusion criteria apply
Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy - Observational Program (Study P04816)

The purpose of this program is to evaluate the safety, tolerability, and efficacy of the new concomitant and sequential temozolomide regimen in newly diagnosed Glioblastoma patients in a routine care setting.

Participant sampling method: consecutive patient sampling.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed Glioblastoma multiforme

Exclusion Criteria:

* History of hypersensitivity to temozolomide or its components, or to dacarbazine.
* Women who are pregnant or breast-feeding.
* Patients with severe myelosuppression.
The Role of Circ0014614 in the Formation and Development of ET

Research on the Role of Circ0014614 in the Formation and Development of ET

In recent years, tumor niche involved in the development of myeloproliferative disease（MPN）, which is remodelled by stem progenitor cells driving gene mutation, has attracted attention, but the reason and mechanism of remodelling microenvironment by mutated hematopoietic stem cells（ HSCs） are poorly understood. Our previous studies have shown that there is an obstacle in the transport of extracellular vesicles circ0014614 from MEPs in ET patients, which is enriched in the cytoplasm of megakaryocyte-erythroid progenitor（MEPs）, causing abnormal proliferation and reduced apoptosis of MEPs. The amplified MEPs affect the ossification of Mesenchymal stem cells（MCSs）. Based on this, we propose a hypothesis that circ0014614 may cause abnormal amplification of MEPs, reshape niche, induce ossification of MCSs, and abnormal amplification of osteoblasts（OBCs） through a certain pathway, promoting the formation and development of ET. This study will expand the collection of bone marrow samples from Essential thrombocytosis（ET） patients, detect the differences in circ0014614 levels in peripheral blood and bone marrow before and after treatment, and predict its downstream microRNA and mRNA through bioinformatics analysis to speculate its role in the occurrence and development of the disease. In recent years, tumor niche involved in the development of MPN, which is remodelled by stem progenitor cells driving gene mutation, has attracted attention, but the reason and mechanism of remodelling microenvironment by mutated HSCs are poorly understood. Our previous research has shown that there is an obstacle in the transport of extracellular vesicles circ0014614 from MEPs in ET patients, which is enriched in the cytoplasm of MEPs, causing abnormal proliferation and reduced apoptosis of MEPs. The amplified MEPs affect the ossification of MCSs. Based on this, we propose a hypothesis that circ0014614 may cause abnormal amplification of MEPs, reshape niche, induce ossification of MCSs, and abnormal amplification of OBCs through a certain pathway, promoting the formation and development of ET. This study will expand the collection of bone marrow samples from ET patients, detect the differences in circ0014614 levels in peripheral blood and bone marrow before and after treatment, and predict its downstream microRNA and mRNA through bioinformatics analysis to speculate its role in the occurrence and development of the disease.

Eligibility Criteria:
Inclusion Criteria:

1. According to the classification and diagnostic criteria of hematological myeloid tumors by WHO 2016, patients diagnosed as ET are standardized
2. Voluntary signing of informed consent form
3. Age ≥ 18 years old, regardless of gender
4. No pregnancy plan during treatment

Exclusion Criteria:

1.The researcher judged that it was not suitable to participate in this study
Exenatide and Weight Loss for Diabetes Prevention

Exenatide, a GLP-1 agonist approved for lowering blood glucose concentrations in patients with type 2 diabetes, has been associated with restoration of the first-phase insulin response when administered intravenously to patients with type 2 diabetes. In longer clinical trials, it is associated with progressive decreases in body weight, and improvement in the dyslipidemia that characterizes insulin resistance, although insulin resistance was not quantified. The investigators will seek to determine whether exenatide would have similar effects in individuals who were not diabetic. in particular, the drug effect on beta cell function and insulin sensitivity would be subject to less confounding by changes in blood glucose in the prediabetic population, allowing for clearer evaluation of the physiological effects of the drug on these metabolic endpoints. The investigators will compare 2 groups of prediabetic insulin resistant individuals, all on a weight loss diet and one group on exenatide and the other on placebo. The investigators will evaluate restoration of first phase insulin response, potential glucose lowering effects, including both reversal of prediabetes and hypoglycemia, and improvement in insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Men and women, BMI 27-37kgm2, Fasting plasma glucose = or \> 100 mg/dL and = or \< 99 125m g/dl or a 2 hour post OGTT = \> 140 mg/dl or = or \< 199 mg/dl

Exclusion Criteria:

* Diabetes, Active cardiac, kidney, liver, pulmonary, or other major organ diseases are cause for exclusion. Other exclusionary criteria include: use of corticosteroids, diet medications, antipsychotic medications, history of eating disorder, history of bariatric surgery, active malignancy, recent weight change of more than 2%, inability to attend follow-up visits, excessive alcohol use, investigator's discretion that it is not in patient's best interest
Median Sevoflurane Concentration for Hypotension Between Young and Elderlypatients: Adaptive Clinical Trial

Two arms: elder group, young group. Dixon's up and down adaptive methodology for ED50. Executed after Anesthesia induction for 10min without touching the patient after starting mechanical ventilation.

This adaptive clinical trial will vary target end tidal sevoflurane by 0.4, then by 0.2 and by 0.1 thereafter in order to minimize sample size.

Eligibility Criteria:
Inclusion Criteria:

* Understands experiment, is voluntary, signs informed consent;
* Does not take medication that influences arterial pressure;
* Normotensive.

Exclusion Criteria:

* Received any medication that influences arterial pressure before experiment;
Percutaneous Intramedullary K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures

This study is to improving outcome of pediatric both bone forearm fractures using minimally invasive procedure by intramedullary K-wires.

Most shaft injuries present no unusual challenges and require nothing more than skillful closed reduction and cast immobilization due to the unique property of the growth potential of the immature skeleton. There is a relatively high incidence of re-displacement, malunion and consequent limitation of movement. Perfect anatomical reduction is not always necessary since remodeling of malunion may correct any residual deformity. Angulation has been shown to affect the range of pronation and supination of the forearm.

The most common indications for surgery are failure of closed reduction, open fractures, and fracture instability. When operative intervention is indicated different techniques can be employed such as intramedullary nailing, osteosynthesis with plate and screws fixation and external fixators. Intramedullary nailing has been shown to produce excellent clinical results and in contrast to plate fixation is considered as a minimal invasive procedure.

Surgical technique of K-wires :

After administration of anesthesia, surgery will be performed with the patient supine on the operating table and fracture will be analyzed with an image intensifier. In radius, the wire will be inserted by surgical drilling through Lister's tubercle or the radial styloid while in ulna, the wire will be inserted through the tip of the olecranon.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are younger than the age of 10 years old from both genders and suffering from displaced fractures of shaft both bone of the forearm;
2. Standard preoperative anteroposterior (AP) and lateral forearm radiographs;
3. Complete clinical and radiographic data.

Exclusion Criteria:

1. Poly-traumatized patients with other associated fractures;
2. Undisplaced fractures;
3. Open fractures;
4. Pathological fractures;
5. Malignancy;
6. Malnutrition;
7. Chronic diseases as renal, hepatic, cardiac patients;
8. Incomplete radiographic data.
Phosphorylcholine PC-mAb Effects in Subjects With Elevated Lipoprotein a

Inflammation and abnormal amount of lipids in the blood are key factors for the development and progression of atherosclerosis (thickening of the artery wall) and cardiovascular disease. Lipoprotein (a) is a pro-inflammatory plasma lipoprotein that is believed to be a risk factor for cardiovascular diseases. Vascular inflammation generates a range of effects, including endothelial dysfunction and migration of white blood cells into the vessel wall, which results in increased risk of cardiovascular events.

This study is designed to assess the effects of multiple monthly intravenous infusions with the fully human antibody called PC-mAb, in subjects with elevated lipoprotein (a).


Eligibility Criteria:
Major inclusion criterion:

* Lp(a) above 50 mg/dL at screening

Major exclusion criteria:

* Medical history of myocardial infarction (MI) or stroke within 12 months of screening
* Ongoing or paroxysmal atrial fibrillation
* Clinically overt heart failure
* Hypertension defined as ≥180/100 mmHg
* Diabetes mellitus
* Systemic autoimmune diseases requiring treatment
* Cancer, excluding basal cell carcinoma, within the last five years