cyrilzakka/clinical-trials huggingface dataset:
Evaluate Early Invasive Strategy for Patients With STEMI Presenting 24-48 Hours From Symptom Onset

The primary objective of the trial is to evaluate the efficacy of early invasive strategy for STEMI patients within 24-48h of symptom onset.

At present, timely primary percutaneous coronary intervention (PCI) is the preferred strategy for ST-segment elevation myocardial infarction (STEMI) patients within 24h of symptom onset. In stable STEMI patients presenting 12 to 48 hours from symptom onset, BRAVE-2 Trial (n = 365) showed improved myocardial salvage and 4-year survival in patients treated with primary PCI compared with conservative treatment alone. However, data is scarce about the reperfusion strategy focusing on STEMI patients within 24-48h of symptom onset. Further investigations are warranted to explore the best timing of invasive strategy for STEMI patients within 24-48h of symptom onset.

Given that no randomized clinical trial is designed especially for STEMI patients within 24-48h of symptom onset, and limited data is available to evaluate the efficacy of early invasive strategy for the special subgroup of STEMI patients, investigators plan to perform a controlled, randomized trial to evaluate the efficacy of early invasive strategy for STEMI patients within 24-48h of symptom onset.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 or over and less than 75 years old;
2. ECG: a) ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads; or b) new or presumable new left bundle branch block in the presence of typical symptoms;
3. Patents with STEMI with symptom onset between 24 and 48 hours before randomization;
4. Signed informed consent form prior to trial participation.

Exclusion Criteria:

1. Patents with STEMI with symptom onset \<24h or \>48h or uncertain time onset.
2. Prior administration of thrombolytic therapy or attempted PCI before randomization;
3. Presence of indications for primary PCI, such as persistent chest pain, cardiogenic shock, life-threatening arrhythmias or cardiac arrest, severe acute heart failure, and mechanical complications;
4. Coagulopathy, active peptic ulcer, history of cerebral or subarachnoid hemorrhage, stroke within 6 months, other contraindications for antiplatelet or anticoagulant therapy;
5. Known intolerance to antiplatelet (e.g. aspirin, clopidogrel, ticagrelor) and anticoagulant therapy (e.g. heparin, bivalirudin);
6. Presence of contraindications for CMR;
7. Congenital heart disease or severe valvular disease;
8. eGFR \<30 ml/min/1.73 m2;
9. History of malignant tumors;
10. Combined with other diseases and life expectancy ≤12 months;
11. Pregnancy;
12. Inclusion in another clinical trial;
13. Inability to provide informed consent or not available for follow-up judged by investigator.
Sero-conversion Study for a Two-dose Schedule of Sabin IPV in China

This study aims to obtain the direct domestic IPV vaccine monitoring data for the CNBG products, and provide scientific evidence for the National Immunization Program and long-term polio vaccine immunization policy.

The overall objective of this research is to determine the seroconversion rates of two reduced Sabin IPV schedules in Chinese children - a 2-dose schedule and a 3-dose schedule.

In April 2017, WHO/SAGE recommended that a two-dose, IPV-only schedule can be used after polio eradication, with a schedule seroconversion target of at least 90%. The recommendation was based in part on a study conducted in Cuba using Salk-IPV at 4 months and 8 months of age. However, for domestic Sabin IPVs, there are no such data to support a 2-dose schedule among Chinese infants.Two Sabin IPV products that are available to China's National Immunization Program - produced by Kunming Bio institute and China National Biotec Group (CNBG).The monitoring study on sIPV produced by Kunming Bio institute has already applied for approval.This study aims to obtain the direct domestic IPV vaccine monitoring data for the CNBG products, and provide scientific evidence for the National Immunization Program and long-term polio vaccine immunization policy.

The overall objective of this research is to determine the seroconversion rates of two reduced Sabin IPV schedules in Chinese children - a 2-dose schedule and a 3-dose schedule.

The specific objectives of the study are to:

1. Determine whether the seroconversion rate is above 90% with a 2-dose Sabin IPV schedule, with the first dose given at 4 months and the second dose given ≥4 months after the first dose.
2. Measure neutralizing antibody titers against poliovirus type I, II and III among two-dose Sabin IPV alone schedule, compared with three-dose Sabin IPV alone schedule.

Eligibility Criteria:
Inclusion Criteria:

* Parent or legal guardian agree to participate in our study.
* The family is living locally with legal residency status.

Exclusion Criteria:

* Parent or legal guardian does not agree to participate in our study.
* The potential subject has received IPV or OPV before 4 months of age in the two-dose schedule group.
* The potential subject has one or more contraindications to IPV (although we will note the contraindications).
Irinotecan/Cetuximab Followed by XELOX/Cetuximab vs the Reverse Sequence in Metastatic CRC

This phase II study will evaluate which is the best way to administer cetuximab after recurrence in 1st line irinotecan+bevacizumab based treatment and to obtain results of the efficacy of the oxaliplatin+cetuximab combination as 2nd line treatment.

Because of the recent advances in the field of systemic chemotherapy for mCRC, like irinotecan, oxaliplatin, capecitabine, and targeted agents (Cetuximab, Bevacizumab) mCRC patients have an overall survival that in some cases reaches 25 months.Irinotecan is an inhibitor of the DNA enzyme topoisomerase I, with use in clinical practice for the last 10 years.In a phase II study with mCRC patients resistant to irinotecan based therapy the combination of irinotecan and Cetuximab (an IgG1 anti-EGFR antibody) yielded a response rate of 22.5%.Capecitabine was shown to have improved tolerability and response rate compared with bolus 5-FU, with comparable time to progression and survival.Oxaliplatin has been approved by the FDA for 2nd line treatment in the metastatic CRC setting as a number of trials have shown promising data for response rates, disease stabilization rates,median progression free survival (PFS) and overall survival (OS).KRAS is a predictive marker for clinical benefit from EGFR-based antibody treatment. KRAS is the first molecular marker for selection of a targeted therapy in combination with a standard chemotherapy regimen. Patients with KRAS wild-type tumors have a strong benefit from the administration of cetuximab with better PFS and objective responses.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally advanced or metastatic colorectal cancer
* Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
* ECOG performance status ≤ 2
* Age 18 - 72 years
* Patients who have had a CR, PR or SD after 1st line therapy based on Irinotecan+Bevacizumab
* Paraffin block from the primary tumor in order to perform tha mutational analysis of the KRAS gene
* Adequate liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 4 upper normal limit, ALP ≤ 2.5 upper normal limit),renal (Creatinine ≤ 1.5 upper normal limit) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥100,000/mm3) function
* Patients must be able to understand the nature of this study
* Written informed consent

Exclusion Criteria:

* Presence of central nervous system or brain metastases
* Pregnant or lactating woman
* Life expectancy \< 3 months
* Previous radiotherapy within the last 4 weeks or \> 25% of bone marrow or in the field where the treatment target is located
* Peripheral neuropathy grade ≥2
* Known hypersensitivity to Erbitux
* Metastatic infiltration of the liver \>50%
* Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy
* Active infection
* Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
* Psychiatric illness or social situation that would preclude study compliance
Ultrasound Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients

The current study was conducted to examine the effect of ultrasound acupuncture for oxaliplatin-induced peripheral neuropathy in colorectal cancer patients.

Oxaliplatin is platinum-based chemotherapy most usually used for the treatment of metastatic colorectal cancer, this drug can produce a cumulative and dose-limiting distal sensory neuropathy affecting the majority of oxaliplatin-treated patients. Despite intense investigation at the preclinical and clinical levels, no treatment can be suggested for the prevention of OIPN. Since acupuncture has proven effective in alleviating the severity of peripheral nerve neuropathy, as has ultrasound.

This systematic review was conducted to test the ability of ultrasound acupuncture in decreasing neuropathy-related symptoms induced by oxaliplatin-based chemotherapies in colorectal cancer patients

Eligibility Criteria:
Inclusion Criteria:

-

The subject selection was according to the following criteria:

* Adults their ages ranged from 20 to 70 years old.
* Receiving or have received chemotherapy treatment for colon or rectal cancer.
* Chemotherapy regimen included the agent oxaliplatin.
* Patients diagnosed with neuropathy by the oncologist.
* Both sexes.
* No neuropathy prior to oxaliplatin treatment.
* No documented or observable psychiatric or neurological disorders that would interfere with study participation (eg, dementia or psychosis)
* Stage II, III and IV colon or rectal cancer.
* Hands and Feets were the most affected by CIPN.
* The first dose of oxaliplatin was from 4 months or more.

Exclusion Criteria:

* The potential participants were excluded in the following conditions:

  * Another malignancy
  * Patients with severe or unstable cardiorespiratory or musculoskeletal diseases that may influence the accuracy of quantitative sensory testing results.
  * Participants who cannot remain on the same medications throughout the study period with minor dose adjustments allowed.
  * Contraindications to therapeutic ultrasound including active cancer in region of hands or feet, presence of deep vein thrombosis, complete numbness in hands or feet (representing severe CIPN), metal or plastic implantation
  * Peripheral vascular disease in hands or feet.
An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression

The purpose of this study is to evaluate the effectiveness of two adaptive treatment strategies (ATSs) for adolescent depression. The ATSs include delivery of an evidence-based psychotherapy (interpersonal psychotherapy for depressed adolescents, IPT-A), systematic symptom monitoring, and an empirically-derived algorithm that specifies whether, when, and how to augment IPT-A. Two hundred depressed adolescents (age 12-18) will be recruited to participate in a 16-week sequential multiple assignment randomized trial conducted in outpatient community mental health clinics. Adolescents will be randomized to the IPT-A ATS condition or the community clinic's usual care (UC). Adolescents in the IPT-A ATS condition who are insufficient responders will be randomized a second time to the addition of a selective serotonin reuptake inhibitor (SSRI) or more intensive IPT-A (delivered twice per week). Research assessments will be administered at baseline and at weeks 4, 8, 12, 16, and 36.


Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-V criteria for a primary diagnosis of Major Depressive Disorder, Persistent Depressive Disorder, or Depressive Disorder NEC
* Current significant depressive symptoms (based on Children's Depression Rating Scale - Revised \[CDRS-R\] \& Beck Depression Inventory-II \[BDI-II\])
* Current impairment in psychosocial functioning (based on Children's Global Assessment Scale \[CGAS\])

Exclusion Criteria:

* Non English-speaking
* Meet DSM-V criteria for bipolar disorder, psychosis, anorexia nervosa, substance use disorder, autism spectrum disorder, or intellectual disability disorder.
* Adolescents who are actively suicidal with a plan and/or intent who are assessed to need a higher level of care than outpatient treatment due to safety risk will be referred for appropriate level of stabilization. Once stabilized, the adolescent can be re-evaluated for eligibility to participate in the study.
* Currently taking medication for a psychiatric diagnosis other than ADHD
* Females who are pregnant, breastfeeding, or having unprotected sexual intercourse, due to the possibility of randomization to treatment with an SSRI.
Impact of Consumption of Oats in Lipid Profile of Children and Adolescents With Dyslipidemia

Atherosclerosis is the leading cause of death and disability in adults. However, investigations suggest that the basic pathology of heart disease as more severe myocardial infarction which usually reach mainly middle-aged or above, starts from childhood. Hypercholesterolemia is one of the most important risk factors for atherosclerosis in adults and children, is associated with early deposition of lipids in the aorta and coronary arteries.

Among other recommendations for prevention and treatment of heart disease and risk factors, is the recommendation to encourage the intake of soluble fiber. The oats, a major source of soluble fiber, has been recognized as a potential component of the diet to lower blood cholesterol levels, this effect is attributed mainly to the beta-glucan, a type of soluble fiber present in large quantities in oats. In 1997 the Food and Drug Administration admitted that the oat bran, oat flakes and oatmeal may have beneficial effects for health with the recommendation of daily intake of 3g of beta-glucan from oats and a food that brings a claim for promotion health, must provide, without enrichment, at least 1 gram of beta-glucan per serving.

The objective of this project will be compared by randomized clinical trial, the impact of intake of oats, for 8 weeks in the lipid profile of children and adolescents with dyslipidemia.

Will be included in the study 120 volunteers aged between 5 and 16 years who are in nutritional monitoring for at least 1 month. The subjects will be randomly divided into 2 groups, with a control group and another intervention will receive 3 tablespoons of soup filled with oat bran, which corresponds to 3g of beta-glucan, along with breakfast, lunch and dinner. Patients will be monitored with consultations on the 2nd, 4th and 8th weeks of treatment. Blood sample will be performed, to obtain the lipid profile of patients, at the beginning and end of the study. To compare the groups are used Student's t and squared chi. The alpha of 0.05 is considered critical. The program will be used Statistical Package for the Social Sciences (SPSS) version 15.0.

It is expected a decrease in serum levels of total cholesterol and LDL-c. Thus, living habits and healthy alternatives to prevent these risk factors should be done since childhood, especially in children who already have cholesterol levels of change.


Eligibility Criteria:
Inclusion Criteria:

* Male/Female
* Age limits 5 years-16 years
Cytokine Hemoadsorption in ECMO Patients

Cytokine hemoadsorption is a novel therapy used to improve outcome in critically ill patients with a dysregulated cytokine response and hemodynamic instability. Patients on extracorporeal membraneous oxygenation (ECMO) often develop severe systemic inflammatory response syndrome (SIRS). Cytokine removal using different types of hemoadsorption devices is believed to block the vicious circle of inflammation dysregulation when other basic therapeutic measures fail. To date there are very limited reports on ECMO and cytokine hemoadsorption combination therapy. The aim of this retrospective study is to evaluate feasibility and effectiveness of hemoadsorption in veno-arterial and veno-venous ECMO patients.


Eligibility Criteria:
Inclusion Criteria:

* VA/VV ECMO
* hemoadsorption
* Age ≥ 18 years

Exclusion Criteria:

* no additional exclusion criteria after being eligible for ECMO
Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.

This study consisted of two phases, a Screening/Eligibility Phase and a Treatment Phase. Both phases required the patient to complete an overnight stay.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of either open-angle glaucoma or ocular hypertension in both eyes.
* Willing and able to attend all study-related visits and be housed overnight at clinical site for the study assessments.
* Must sign an Informed Consent form.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential if pregnant, breastfeeding, or not using adequate birth control.
* Severe central visual field loss in either eye.
* Chronic, recurrent or severe inflammatory eye disease.
* Ocular trauma or ocular surgery within the past 6 months.
* Ocular infection or ocular inflammation within the past 3 months.
* Clinically significant or progressive retinal disease.
* Other ocular pathology, including severe dry eye, that may in the opinion of the investigator preclude the administration of study medication.
* Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
* Any medical condition that would preclude the safe administration of a topical beta-blocker.
* Cannot safely discontinue all glucocorticoids administered by any route.
* Other protocol-specified exclusion criteria may apply.
Effect of Different Non-surgical Treatment Approaches of Peri-implantitis

Peri-implantitis is a biofilm-associated pathological condition characterized by inflammation within the peri-implant mucosa, which leads to the progressive loss of the surrounding supporting bone tissue. The primary goal of managing peri-implantitis is to control the peri-implant biofilm and resolve inflammation. Nonsurgical treatment of peri-implantitis by submarginal mechanical instrumentation alone typically provides clinical improvements, particularly in non-advanced cases. However, to ensure surface decontamination and enhance treatment outcomes, alternative or adjunctive methods, such as systemic/local antibiotics, antiseptics, lasers, and air-abrasion systems, have been proposed.

Therefore, the null hypothesis (H0) of the present study is that no statistically significant difference would be detected in clinical inflammation signs among patients diagnosed with early-stage peri-implantitis after undergoing one of the following treatments: nonsurgical mechanical instrumentation alone, mechanical instrumentation plus chlorhexidine (CHX), mechanical instrumentation plus gaseous ozone, mechanical instrumentation plus glycine air polishing, or glycine air polishing alone.


Eligibility Criteria:
Inclusion Criteria:

* the presence of at least one titanium implant with clinical and radiographic signs of initial to moderate peri-implantitis
* single-unit or partial restorations without overhangings
* absence of occlusal overload
* the presence of at least 2 mm of keratinized attached peri-implant mucosa
* periodontally healthy participants with a good level of oral hygiene

Exclusion Criteria:

* the presence of implant mobility
* systemic diseases (i.e. diabetes (HbA1c \<7), osteoporosis, bisphosphonate medication) which could affect the outcome of treatment
* smoking
* placement, and prosthetic loading of implants within the past year
Correlation Between Circulating Resistin and Vascular Inflammation Measured by 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) (18FDG-PET)

Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis.Resistin was shown to induce vascular endothelial dysfunction and vascular smooth muscle cell proliferation.

18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore, the purpose of the study is to demonstrate the correlation between circulating resistin and vascular inflammation detected by 18FDG-PET in obese persons.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers for visiting routine medical check in our clinic

Exclusion Criteria:

* History of cardiovascular disease (myocardial infarction, unstable angina,stroke, or cardiovascular revascularization)
* Diabetes
* Hypertension
* Malignancy
* Severe renal or hepatic disease
* Subjects taking medications that might affect inflammation such as non-steroidal anti-inflammatory drugs (NSAIDs) and statin
TOxicity After Radiotherapy in breAst CancEr Survivors (ThORACeS) - A Retrospective Cohort Study

Rationale:

The number of breast cancer (BC) patients at risk for long-term radiation-induced health problems is increasing, as their outcome is improving due to intensified treatment regimens, such as new systemic approaches and radiotherapy. Therefore, identifying BC survivors with the highest risk for radiation-induced health problems is crucial for developing strategies for primary and secondary prevention, which may contribute to healthy ageing.


Eligibility Criteria:
Inclusion Criteria:

* Female gender.
* Treated for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS).
* Treated with curative breast-conserving surgery followed by radiotherapy of the breast, with or without irradiation of the regional lymph nodes.
* Start of radiotherapy is between 01-01-2005 and 31-12-2008.
* Available planning CT scan and dose distribution data of original breast cancer irradiation.

Exclusion Criteria:

* Any prior malignancy other than non-melanoma skin cancer or breast cancer.
* Prior radiotherapy treatments in the thoracic region.
* Treated with neoadjuvant chemotherapy.