cyrilzakka/clinical-trials huggingface dataset:
ADVANTAGE® Prosthetic Heart Valve Long-term Follow-up Trial

The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve.

The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve in patients who were already implanted with this device.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the ADVANTAGE Prosthetic Heart Valve Study in Herz- und Diabeteszentrum (Bad Oeynhausen) or Deutsches Herzzentrum (Munich)
* Signed and dated patient data release form
* Available for follow-up

Exclusion Criteria:

* High probability of non-adherence to physician's follow-up requirements
Outcome of Cardiac Arrest Patients Following Guidelines Implementation Over the Years

The study aims to evaluate the level of local implementation of the new interventions introduced by the guidelines for post-cardiac arrest management and their impact on the survival of patients resuscitated from cardiac arrest and admitted to intensive care over a 14-year period. During this time period, the European Resuscitation Council (ERC) and the European Society of Intensive Care Medicine (ESICM) introduced three new guidelines for post-cardiac arrest management, each five years apart: the 2010, 2015, and 2021 guidelines.

This study is a retrospective multicenter cohort observational study (two centers involved: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and Fondazione IRCCS San Gerardo dei Tintori).

All patients admitted to the Intensive Care Units (ICU) of the hospitals involved in the study from January 1, 2011, to May 30, 2024, following cardiac arrest of any etiology, who meet the inclusion and exclusion criteria, will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Patients resuscitated from cardiac arrest and admitted to intensive care unit
* Age ≥ 18 years
* Out-of-hospital and in-hospital cardiac arrest
* Cardiac arrest of any etiology

Exclusion Criteria:

* Pediatric patients (\<18 years)
* Patients not admitted to one of the aforementioned intensive care units.
Addressing Microaggressions in Racially Charged Patient-provider Interactions: A Pilot Randomized Trial

Racial bias in medical care is a significant public health issue, with increased focus on microaggressions and the quality of patient-provider interactions. Innovations in training interventions are needed to decrease microaggressions and improve provider communication and rapport with patients of color during medical encounters. This paper presents a pilot randomized trial of an innovative clinical workshop that employed a theoretical model from social and contextual behavioral sciences. The intervention was largely informed by research on the importance of mindfulness and interracial contact involving reciprocal exchanges of vulnerability and responsiveness, to target processes centered on the providers' likelihood of expressing biases and negative stereotypes when interacting with patients of color in racially challenging moments. Twenty-five medical student and recent graduate participants were randomized to a workshop intervention or no intervention. Outcomes were measured via provider self-report and observed changes in targeted provider behaviors. Specifically, two independent, blind teams of coders assessed provider emotional rapport and responsiveness during simulated interracial patient encounters with standardized Black patients who presented specific racial challenges to participants. We observed greater improvements in observed emotional rapport and responsiveness (indexing fewer microaggressions), improved self-reported explicit attitudes toward minoritized groups, and improved self-reported working alliance and closeness with the Black standardized patients were observed and reported by intervention participants. Effects largely were driven by improvements by the White participants.


Eligibility Criteria:
Inclusion Criteria:

* Medical students or recent graduates of Bastyr University.

Exclusion Criteria:

* None
Effect of Gastrectomy and Anastomosis on Diabetes and Hypertension in Early Gastric Cancer Patients

The purpose of this study is to determine whether the extent of gastrectomy and anastomosis type affect chronic metabolic disease such as diabetes and hypertension in early gastric cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven primary gastric adenocarcinoma
* clinical stage Ia or Ib examined with endoscopy, endoscopic ultrasound, and computed tomography
* aged 20-80 year old,
* performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
* diagnosed as diabetes or hypertension
* patients planning to undergo gastrectomy or endoscopic submucosal dissection
* written informed consent

Exclusion Criteria:

* having high risk for operation such as severe heart disease, severe respiratory disease
* pregnant
* previous abdominal surgery or radiation therapy
* proven more advanced disease than pathological stage II requiring adjuvant chemotherapy
Improve the Survival Rate of Chinese Children and Adolescents With Non-Hodgkin's Lymphoma

Non-Hodgkin's lymphoma is an aggressive malignance disease in children and adolescents. This study was designed to evaluate the efficacy and toxicity of the modified NHL-BFM-90 protocol in Chinese children and adolescents with Non-Hodgkin's lymphoma.

Non-Hodgkin's Lymphoma (NHL) in children and adolescents include Burkitt's lymphoma (BL), diffuse large B cell lymphoma (DLBL), anaplastic large cell lymphoma (ALCL) and lymphoblastic lymphoma (LBL). These subtypes of NHL are an aggressive group of diseases. At present, in developed countries, 80 to 90% of children with NHL are cured by intensive, risk-adapted chemotherapy.The best protocols include BFM-90, LMB-89 and FAB/LMB/96. However, in developing countries, such as those with low and moderate incomes, the limited availability of resources is an obstacle for using these complicated and intensive protocols.As such, very simple protocols, such as the CHOP protocol, were often used to treat children and adolescents with NHL, thus resulting in poor survival rates. To improve the survival rate of Chinese children and adolescents with NHL, This study was designed to evaluate the efficacy and toxicity of this modified NHL-BFM -90 protocol in Chinese children and adolescents with NHL.

Eligibility Criteria:
Inclusion Criteria:

1. Untreated children and adolescents with Non-Hodgkin's lymphoma
2. Age ≤ 20 years
3. The informed consent of their guardians was obtained.

Exclusion Criteria:

1. Recurrence Non-Hodgkin's lymphoma
2. Age \>20 years
3. No abide by the protocol
Genetics in Non-response to Anti-VEGF Treatment in Exudative AMD

To assess genetic features and intraocular cytokine profiles of non-responders to anti-VEGF treatment of exudative age-related macular degeneration. Also to assess necessity and frequency of pro re nate medical re-treatment.


Eligibility Criteria:
Inclusion Criteria:

* active subfoveal CNV related to exudative age-related macular degeneration (all subforms)
* age \> 60 years
* visual acuity \> 20/400
* no previous treatment for AMD

Exclusion Criteria:

* any previous AMD therapy
* other CNV types (myopic, parapapillary)
* contraindication for ranibizumab treatment
* prior study participation for AMD
* pregnancy / premenopausal women
Effectives of Non-extraction Orthodontic Treatment of Angle Class I Malocclusion

Introduction: The investigators aimed to evaluate the effectiveness of non-extraction orthodontic treatment for Angle class I malocclusion.

Many people are also concerned about their oral health. When social communication is more important, aesthetic concerns also receive a lot of attention. A beautiful smile can boost self-assurance and empathy. Angle class I malocclusion is prevalent, and dental malocclusion is a significant percentage of the population at all ages . Tooth extraction is a controversial topic in orthodontics, with the general view being against it. Angle and his students argued against it, but Charles Tweed saw recurrence in the 1930s after retreatment without extraction and retreatment with extraction. The use of tooth extraction therapy increased in the 1960s but has become less common since the late 20th century. The science of orthodontics has made significant advancements under the principle of least invasiveness, but the debate remains about whether to consider tooth extraction. The contemporary view believes that the majority of patients may and should be treated without tooth extraction, but in rare circumstances, extraction is necessary to make up for crowding and excessive incisor protrusion that harm the beauty. In truth, each individual must be thoroughly evaluated in light of their bite, cosmetic condition, and stability in the wake of therapy before any course of action is recommended. The investigators aimed to evaluate the effectiveness of non-extraction orthodontic treatment for Angle class I malocclusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients (≥ 15 years) with indicated Angle class I malocclusion and missing space ≤9mm
* Cervical vertebral maturation stages 5, 6, (CS5, CS6): cervical vertebrae 2, 3, and 4 have a concave curved lower border and have at least one rectangle C3, C4 cervical vertebra upright or at least square
* No prior orthodontic treatment
* Fully erupted permanent teeth (except third molars)
* Voluntary research participation

Exclusion Criteria:

Face soft tissue surgical procedures, periodontal disease, and maxillofacial congenital anomalies
A Study With Tarceva and Chemotherapy vs. Chemotherapy Alone in Patients With Advanced Lung Cancer

The purpose of this study is to determine if Tarceva plus standard chemotherapy is more effective than standard chemotherapy alone in the treatment of lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age \>=18 years
* Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NSCLC)
* A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology)
* Measurable or non-measurable disease
* ECOG performance status of 0 or 1
* Life expectancy of \>=3 months
* \>= 3 weeks since any prior surgery or radiotherapy (\>=2 weeks for patients who receive \<=30 Gy of radiotherapy involving \<25% of the marrow reserve)
* Use of an effective means of contraception (women of childbearing potential)
* Able to comply with study and follow-up procedures

Exclusion Criteria:

* Evidence of small cell, carcinoid, or mixed small cell/non-small cell histology
* Malignancies within 3 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
* Symptomatic or untreated brain metastases
* Prior systemic chemotherapy for NSCLC
* Prior exposure to agents directed at the HER axis (e.g., ZD1839 \[Iressa\], C225 \[Cetuximab\], Trastuzumab \[Herceptin\])
* Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible)
* History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
* Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption
* Pregnancy or lactation

Any of the following abnormal baseline hematologic values:

* Granulocytes count \<=1500/uL
* Platelet count \<100,000/uL

Any of the following abnormal baseline liver function tests:

* Serum bilirubin \>1.5× upper limit of normal (ULN)
* Serum ALT and AST \>=2.5× ULN (\>5× ULN if due to liver metastases)
* Alkaline phosphatase \>=2.5× ULN

Other baseline laboratory values:

* Serum creatinine \>1.5× ULN or creatinine clearance \<60 mL/min
* Uncontrolled hypercalcemia (\>11.5 mg/dL)
ORKA-001 in Healthy Volunteers

This is a Phase 1, First-in-human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ORKA-001 in Healthy Participants.

This is a single center, phase 1, double-blind, placebo-controlled, randomized, first-in-human (FIH), single ascending dose study evaluating the safety, tolerability, and pharmacokinetics (PK) of ORKA-001 in healthy volunteers. The study will enroll approximately 24 healthy volunteers. The ORKA-001 dose will be administered by a subcutaneous injection.

Eligibility Criteria:
Key Inclusion Criteria:

1. Healthy male or female participants
2. 18 to 65 years (inclusive) with a body mass index (BMI) 18 to 32 kg/m2
3. Willing and able to remain at the study site unit for the duration of the confinement period and return for the outpatient visit/s defined in the protocol
4. Using a highly effective method of contraception from admission through the end of the study.
5. Willing to abstain from regular, continuous alcohol use or tobacco use as per protocol

Key Exclusion Criteria:

1. Any clinically significant medical condition or finding that, in the Investigator's opinion, is likely to unfavorably alter the risk of study participation, confound study results, or interfere with the study conduct or compliance.
2. Known history of illicit drug use or drug abuse or harmful alcohol use
3. Known history of frequent tobacco or vaping use within 2 years prior to Screening
4. History of severe allergic reactions or hypersensitivity
5. Actively nursing or lactating
6. Use of investigational drug therapy within 30 days prior to enrollment
7. Unable to comply with study requirements or in the opinion of the Investigator should not participate in this study.
The Impact of Dietary Treatment in Patients With Irritable Bowel Syndrome

The obtained results are likely to determine whether changes in the diet of patients with irritable bowel syndrome will affect their nutritional status. They will also allow you to assess whether dietary treatment will affect the resolution or alleviation, or severity of disease symptoms in IBS. The test results can be used in clinical practice.

Participation in the study does not carry any risk of complications associated with undergoing a medical experiment.

This is a randomized, parallel study that includes 1 initial visit and 1 final visit, separated by 8 weeks of diet. The investigators enrolled 73 women in the study, who met the criteria for inclusion in the study, to determine whether changes in the diet of patients with irritable bowel syndrome will affect their nutritional status. At the initial and final visit (after 8 weeks) in all patients, anthropometric measurements, body composition, an interview questionnaire concerning the symptoms of the disease was performed, the intensity of abdominal pain was assessed, the life quality of patients on the IBS-QOL scale was assessed, the calprotectin concentration in the stool was determined and the questionnaire regarding the quantitative assessment of diet was performed. The study population was divided using simple lottery into 3 groups with different dietary treatment for 8 weeks: group 1 - 26 patients - diet with low content of easily fermenting carbohydrates (FODMAP), group 2 - 21 patients - an elimination-rotation diet, and group 3 - (control) - 26 patients - classic diet treatment (recommended by the leading gastroenterologist).

Eligibility Criteria:
Inclusion Criteria:

1. patients with irritable bowel syndrome (mixed) according to Rome III Criteria, in whom the gastroenterologist does not find any other gastrointestinal diseases that may affect this study
2. patients who understand the purpose and nature of the study, agree to its terms and give informed written consent before entering the study
3. who are physically and mentally able to participate in the study and express their will to cooperate

Exclusion Criteria:

1. patients who use strong opioid and psychotropic drugs: barbiturates
2. patients who take part in another clinical trial related to the treatment of gastrointestinal diseases or dietary therapy within 90 days prior to inclusion in this study
3. patients who have a pacemaker or heart defibrillator implanted and metal endoprostheses (due to the used body composition test method (BIA - Bioelectrical Impedance Analysis)
A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

The study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis (RA) with an inadequate response to MTX.

The study objective of Period 2 is to evaluate the long term safety, tolerability, and efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.

The study includes a 35-day screening period; a 14-week randomized, double-blind, parallel-group, controlled treatment period (Period 1); a 246-week blinded extension period (Period 2); and a 30-day follow-up visit.

Participants who met eligibility criteria were to be randomized in a 2:2:1:1 ratio to one of four treatment groups:

* Group 1: upadacitinib 30 mg QD (Period 1) → upadacitinib 30 mg QD (Period 2)
* Group 2: upadacitinib 15 mg QD (Period 1) → upadacitinib 15 mg QD (Period 2)
* Group 3: MTX (Period 1) → upadacitinib 30 mg QD (Period 2)
* Group 4: MTX (Period 1) → upadacitinib 15 mg QD (Period 2)

Starting with implementation of Protocol Amendment 5, all participants in the extension period will receive open-label upadacitinib 15 mg QD, including those currently on upadacitinib 30 mg QD.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA for \>= 3 months.
* Subjects must have been on oral or parenteral MTX therapy \>= 3 months and on a stable dose for \>= 4 weeks prior to first dose of study drug.
* Must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (other than MTX) \>= 4 weeks prior to first dose of study drug.
* Meets the following minimum disease activity criteria: \>= 6 swollen joints (based on 66 joint counts) and \>= 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.

Exclusion Criteria:

* Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
* Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs).
* Current diagnosis of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted.
Bandage Contact Lens Application for the Management of Corneal Abrasion

The researchers are trying to understand if the application of a bandage contact lens results in better relief than usual treatment for a corneal abrasion.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Superficial Corneal Abrasion

Exclusion Criteria:

* Incarceration
* Pregnancy
* Inability to Provide Informed Consent
* Infectious keratitis
* Retained foreign bodies in the eye
* Active infection involving the orbit or periorbital region
* Patients who are not able to or who are deemed unlikely to follow-up with ophthalmology
* A history or recent contact lens wear
* A lack of trauma or an unclear history of trauma as the inciting cause of the abrasion
* Allergy to the antimicrobial solution (POLYTRIM)
* Women who are currently breastfeeding
* Chronic eye drop use
* A history of eye surgery other than cataract surgery (greater than 6 months prior to abrasion)
* Diabetes (Patients with even mild diabetic neuropathy can have decreased pain sensation and also delayed corneal epithelial healing)
* Any eye condition that may be deemed to interfere with the conduct of the protocol or outcome measurement.
Endodontic Treatment of Necrotic Primary Teeth With Guedes Pinto Paste: A Randomized Clinical Trial

The maintenance of primary teeth until their exfoliation has been one of the main purposes of Pediatric Dentistry, are they representing the fundamental basis for proper occlusion of the permanent dentition. Often, injuries or extensive dental caries reach the pulp of deciduous teeth making maintenance on these dependent endodontic treatment arc. Thus, this study was to conduct a randomized clinical trial with longitudinal follow-up of two years, double blind, to compare the degree of success of endodontic treatment in primary among the most used folder, Guedes Pinto paste, and one Calcium hydroxide and iodoform paste to control, Vitapex.

After approval by the ethics committee of the patients Faculty of Dentistry, University of São Paulo that having root canal filling of primary teeth will be invited to participate in the study. A clinical examination and prior radiographic diagnosis and also a quality of life questionnaire regarding oral health (- ECOHIS Early Childhood Oral Health Impact Scale) will be-held. The patient will be randomized to one of two groups and will be held endodontics by a blind handler. The patient will be accompanied with periods of one week, six months, 12 months and 24 months by a blinded evaluator. At the last visit of the review ECOHIS questionnaire will be reapplied to those responsible. The outcome will be the success or failure of endodontic treatments evaluated through permanent tooth in the arch on clinical and radiographic conditions of normality. The longevity of the treatments will be evaluated by estimating survival rates by Kaplan-Meier. The differences between the survival rates according to the type of proposed endodontic treatment will be analyzed using the log-rank test with a minimum significance level of 5%.

Eligibility Criteria:
Inclusion Criteria:

* Primary teeth with pulp diagnosis and need endodontic treatment
* Patients whose guardians consent to their participation in the survey
* fistula or abscess
* bone rarefaction or visual diagnosis
* teeth in the remaining tooth structure and location of the injury rehabilitation permit
* do not have internal or external resorption involving more than one third of the root length
* have no bone loss in lateral root and disruption crypt and the presence of at least half of root

Exclusion Criteria:

* health problems systemic
* congenital facial deformities
* facial tumors
* syndromes