cyrilzakka/clinical-trials huggingface dataset:
Comparative Evaluation of the Effect of Prophylactic Intraligamentary Injection of Dexamethasone and Piroxicam on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis

the study is conducted to assess and compare the efficacy of local intraligamentary injection of glucocorticoids(dexamethasone) and NSAID(piroxicam) on reduction of postoperative pain in patients with symptomatic irreversible pulpitis.


Eligibility Criteria:
Inclusion Criteria:

1. Systemically healthy patient (ASA I or II).
2. Mandibular Posterior teeth with:

   * Preoperative sharp pain.
   * Absence of widening in the periodontal ligament (PDL).
   * Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).

Exclusion Criteria:

1. Patients allergic to anesthetics, piroxicam (any other NSAIDs) or dexamethasone (other corticosteroids).
2. Pregnant or nursing females.
3. Patients having significant systemic disorder (ASA III or IV).
4. Hemostatic disorders or anti-coagulant therapy during the last month.
5. Consumption of opioid or non-opioid analgesics or corticosteroids during the last 12 hrs before treatment.
6. Retreatment cases.
Chinese Version of LIVE-LiFE for Older Adults With Previous Falls

The research is to solve the problem of the high incidence of falls among older adults in China. To this end, the investigators will develop a multi-dimensional fall prevention program by cultivating nursing students as community intervention personnel to address the current shortage of fall prevention programs and professional intervention in China. The research will make an important contribution to health care.

The study intervention group is a 12-week multi-dimensional intervention, consisting of four parts: individualized balance and strength training, vision screening, drug evaluation, home risk assessment and home repair and transformation. Interventors will teach skills related to balance and strength training, incorporate these principles and exercises into daily and leisure activities, and how to increase the challenge of balance. The one-hour home visit aims to develop a personalized plan for participants by understanding each participant's health, exercise preferences, sedentary behaviors, and identifying needs related to the risk of falling. In particular, the interventionist will work with the participant to determine 6 skills or activities, and the participant hopes to practice ankle weight bearing at least 3 times a week based on their interests and abilities. Interventions and participants will work together to develop personal goals and plans, using exercise logs for gradual exercise, to continuously increase strength, resistance, weight, and challenge balance or strength. During home visits, the intervener will also assess participants' inherent risks by assessing their visual acuity, assess their home risk factors, and discuss with their caregiver or their children what risks would arise if the elderly live alone. In addition to group meetings and home visits, the interventionists will call to ask about progress and provide support and encouragement. Participants in the control group will receive the same amount of health education。

Eligibility Criteria:
Inclusion criteria:

* age ≥60 years;
* Falls ≥2 times or injuries caused by falls ≥ 1times in the past year;

Exclusion criteria:

* residents who cannot live in a community in Changsha for more than 3 months, or who reside in a long-term care institution in Changsha;
* Moderate to severe cognitive impairment based on a simple and portable mental state questionnaire;
* Unable to walk independently;
* Has the nervous system condition which seriously affects its gait and activity;
* Any unstable or terminal illness that may interfere with planned exercise and is unlikely to be resolved;
* He is currently undergoing physical therapy.
Pain Perception is Attenuated in Patients With Painless Myocardial Infarction

To explore whether reduced systemic pain perception in response to painful stimuli and personality pain related variables characterizes silent MI patients.

Objective: Silent myocardial infarction (MI) is an event of severe myocardial ischemia without pain experience. The lack of pain alarm leads to increased morbidity and mortality, because the patients do not sick timely medical treatment. This study aims to explore whether reduced systemic pain perception in response to painful stimuli and personality pain related variables characterizes silent MI patients.

Methods: Level of chest pain intensity was assessed by visual analogue scale (VAS), range from 0 (no pain) to 100 (maximal pain). Heat pain threshold, magnitude estimation of supra-threshold painful stimuli at 47ºC as well as pain catastrophizing scores were assessed in 90 acute MI patients (mean age 66±12.1, range 33-79) with chest pain (n=65) and without pain symptoms(n=25). All stimuli were performed by Thermal Sensory Analysis (TSA) and applied to the right forearm.

Results: The demographic variables, history of ischemic heart, risk factors for coronary artery disease, ST-T segment changes on ECG and troponin levels were similar in both groups. Greater intensity of chest pain VAS scores was inversely correlated with lower pain threshold (r= -0.417, p\<0.001), and directly associated with higher pain scores in response to the heat pain (r=0.354, p=0.002). Patients with painful MI demonstrated lower pain threshold (41.9±3.6 vs. 44.9±3.8, p=0.001), higher VAS scores in response to the supra-threshold painful stimuli (50.2 ±21.8 vs. 27.0±25.2, p=0.002), and higher catastrophizing level (10.6±12.0 vs. 5.4±8.8, p=0.032). Chest pain complaint was not related to ST-T changes as well as concomitant diseases.

Conclusions: This study suggests that reduced systemic pain perception as well as cognitive personality variables play an important role in the etiology of Silent MI.

Eligibility Criteria:
Inclusion Criteria:All patients with painless or painful myocardial infarction -

Exclusion Criteria:Patients who can't give informed concent or couldn't cooperate

-
Bibliotherapy for Patients With Cancer

The purpose of this study is to examine the efficacy of a self-help workbook in enhancing a sense of empowerment, coping, quality of life and reducing distress for patients with cancer.


Eligibility Criteria:
Inclusion Criteria:

* 18+ years of age
* been diagnosed with cancer
* can read English

Exclusion Criteria:

-participating in the "Think Smart, Live Well" group
Cognition, Steroids, and Imaging in Cushings Disease

This study investigates the effects of the glucocorticoid hormone cortisol on brain structure and function. Patients with Cushing's disease are studied before and after treatment. Brain imaging and neuropsychologic tests are used to study changes in the hippocampus and thinking and learning functions as well as mood during the period of elevated cortisol. At several intervals after treatment, these are reexamined to study the degree of reversibility of the abnormalities. The contribution of cortisol as well as testosterone and estrogen to dysfunction and recovery is studied. Since elevated cortisol and dysregulation of its secretory system occurs in a significant proportion of the aged and in Alzheimers Disease and Major Depressive Disorder, these studies will help advance knowledge of the role of cortisol in these conditions.


Eligibility Criteria:
Inclusion criteria:

* patients with suspected Cushing's syndrome with clinical findings suggestive of Cushing's syndrome and positive screening tests (urinary free cortisol and low dose overnight dexamethasone suppression test).

Exclusion criteria: none
Efficacy and Safety of HRS-7535 Tablets in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.

2 weeks screening period, 3 weeks run-in period, 16 weeks double-blind treatment period, to evaluate the Safety and Efficacy of HRS-7535 in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and SGLT2i.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, 18-75 years of age at the time of signing informed consent;
2. Have T2DM (based on the 2020 Chinese Diabetes Society \[CDS\] diagnostic criteria)
3. HbA1c为7.5%≤HbA1c≤11.0% at the screening visit；
4. FPG≤15 mmol/L at the screening visit;
5. Have been treated with an SGLT2i with metformin, for at least 8 weeks;
6. At screening and random visit, 20.0 ≤BMI≤ 35.0 kg/m2;
7. Able and willing to provide a written informed consent

Exclusion Criteria:

1. Have type 1 diabetesmellitus;
2. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
3. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;
4. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
5. Surgery is planned during the trial;
6. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
Energetic Abnormalities in Heart Failure With Preserved Ejection Fraction

Up to half of all patients with heart failure are found to have normal pumping function of the heart muscle, but show abnormalities in the way the heart muscle relaxes and fills with blood. These patients often have high blood pressure, and tend to have stiff arteries and stiff heart muscle. We wish to test the hypothesis that these patients have abnormal energy stores in their heart muscle.


Eligibility Criteria:
Inclusion Criteria:

* Clinical features consistent with heart failure
* LVEF ≥ 50%, with no evidence of significant valvular disease, no hypertrophic cardiomyopathy, and no evidence of pericardial constriction
* A peak VO2 \< 80% predicted, with a pattern of gas exchange on metabolic exercise testing indicating a cardiac cause for limitation

Exclusion Criteria:

* Objective evidence of lung disease on formal lung function testing
* Reversible myocardial ischaemia on contrast-enhanced myocardial stress
* Echocardiography, and evidence of exercise-induced mitral regurgitation
* Obesity (BMI \>35) or a locomotor cause for exercise limitation
Pathological Response After Neoadjuvant Treatment on NSCLC

This is a non-interventional, observational, multicenter and retrospective study. Being limited to the collection of patient data already filled in the Tumor Thoracic Registry data base and the data from stage IIIA clinical trials case report forms.

This is a non-interventional, observational, multicenter and retrospective study that will not under any circumstances interfere in the physician's normal clinical practice. Being limited to the collection of patient data already filled in the Tumor Thoracic Registry (TTR) data base and the data from stage IIIA clinical trials case report forms, it does not entail any diagnostic or therapeutic procedure outside of normal clinical practice.

The primary objective is to assess pathological response after neoadjuvant treatment as a subrogate endpoint for overall survival and disease-free survival in resectable stage IIIA non-small cell lung cancer patients.

It is estimated that around 15-20 Spanish sites are enrolling patients with these characteristics in the TTR or in the stage IIIA clinical trials of the Fundación GECP.

Pathologists and physician's of these sites will be invited to participate in the PLANET study as all cases will be clinical-pathologically re-evaluated to reach the study objectives. Each pathologist will re-evaluate the specimens from the selected patients under common criteria.The sample size would be 150 patients enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with resectable stage IIIA disease (according to American Joint Committee on Cancer \[AJCC\] lung cancer edition 7 or 8) who were included in the Tumor Thoracic Registry data base and in stage IIIA clinical trials which the sponsor is Fundación GECP.
* Patients with histologically N2 involvement confirmed
* Patients diagnosed as stage IIIA from 2010 and 2017
* Patients who have received neoadjuvant platinum-based treatment and surgery
* Age ≥ 18 years at time of study entry
* PET /TC at diagnosis

Exclusion Criteria:

* Patients who received chemoradiotherapy neoadjuvant treatment
* Patients who were not resected after neoadjuvant treatment
* Patients who were diagnosed after June 2017
Hemostatic Endothelial Dysfunction in Patients With Peripheral Artery Disease

The study is aimed at evaluating the role of the activity of the key hemostatic parameters of endothelial dysfunction (nitric oxide II (NO) metabolites, plasmin activator inhibitor-1 (PAI-1), von Willebrand factor (vWF), coagulation factor VIII (FVIII), soluble endothelial protein C receptors (sEPCR)) in the development of disease progression, thrombotic complications and restenosis in subjects with atherosclerotic peripheral artery disease.

The study will involve patients with atherosclerotic peripheral artery disease (Rutherford category 3-5). The subjects are to be divided into three groups:

Group A: patients who undergo bypass surgery with a synthetic graft on aorto-iliac or femoro-popliteal segment; Group B: patients who undergo endovascular balloon angioplasty and stenting on aorto-iliac or femoro-popliteal segment; Group C: patients who undergo standard of care conservative treatment.

Decisions on revascularization or conservative treatment alone is to be made by a team of vascular specialists in accordance with the severity of the disease, previous treatment, anatomy, possible need for repeat procedures in the future, and patient's preferences.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females older than 40 years of age;
2. Presence of peripheral arterial disease of atherosclerotic origin.

Exclusion Criteria:

1. Males or females younger than 40 years of age;
2. Chronic lower limb ischemia of other ethiology (Buerger's disease, aortoarteritis etc.);
3. Active cancer or remission period less than 5 years;
4. Decompensated diabetes mellitus;
5. Pregnancy or breast-feeding for females.
18794 - Human Photo Toxicity Test

To determine the phototoxic potential of a topically applied article in human subjects.


Eligibility Criteria:
Inclusion Criteria:

* Be male or female between the ages of 18 and 60 inclusive;
* Be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* Have read and signed the written Informed Consent Form and have completed a HIPAA Authorization Form in conformance with 45CFR Parts 160 and 164;
* Be in general good health as determined by the subject's medical history and in the discretion of the investigator.

Exclusion Criteria:

* Have a visible sunburn;
* Have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses;
* Must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product.
* Have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products.
Omega-6/Omega-3 Ratio and Neural Development in Preterm Infants.

It's known that Docosahexaenoic acid DHA and all Polyunsaturated Fatty Acids PUFA are important in neurodevelopment of term and preterm infants. This study tried to determine the utility of a balanced contribution of DHA and Arachidonic acid AA (omega-6/omega-3) in milk formula, with a ratio similar to that found in breastfeeding, equal to 2, in very premature infants less than 1500 grams and / or less than 32 weeks of gestational age. To evaluate values of fatty acids they have in blood and psychomotor development they achieve.

The study took place in a single-center; it is a prospective randomized study of preterm infants less than 1500 grams and/or less than 32 weeks gestational age, admitted to the Neonatal Intensive Care Unit in the University Clinical Hospital of Santiago de Compostela. They were recruited for a period of 14 months (from July 2010 to august 2011) and followed from birth until 2 years of life.

40 children were included and followed in the study. Patients will be assigned randomly into two groups depending on the type of formula they are receiving. The group A of children will receive a formula supplemented with DHA and ARA with a relationship omega 6/omega 3 = 2. And group B will receive other formula with DHA and ARA, but with a ratio of 1/1.

The classification of group A and B was made by simple random way; one birth in every group, continuously.

Implementation of breastfeeding will be promoted and will be fortified after 7 days of life, when the total amount of breast milk will be more than 1/2 of the total.

When breastfeeding will be insufficient or nonexistent, special formulas for premature babies will be given

During the follow-up of patients, will be measured:

1. - Levels of fatty acids in blood in the first week of life, 3 months, 6 months and 12 months.The determination will be carried out in collaboration with the Hospital de Cruces, Bilbao, Spain.
2. - Evaluation of psychomotor development by Brunet-Lezine scale at 2 years of corrected age.

Eligibility Criteria:
Inclusion Criteria:

Living infants who were less than 1500 grams and/or less than 32 weeks gestational age, and whose parents accepted and subscribed the informed consent

Exclusion Criteria:

* Preterm infants with any malformation or deformation.
* Extreme preterm infants with gestational age less than 25 weeks.
* Infants whose parents couldn't follow up their children in our study center.
* Preterm infants who had a severe intra ventricular hemorrhage (more than grade 2).
* Premature infants who had severe periventricular leukomalacia (more than grade 2) because the latest two conditions can affect neurodevelopment.
* Finally, we excluded neonates who don't need supplementary milk nutrition, i.e. children with breastfeeding only.
The Biology of Chronic Preconditioning: Genomic and Physiologic Mechanisms of Response

The purpose of this study is to assess the effects of repeated RIPC and exercise, on exercise performance, skeletal muscle responses and circulating cellular and humoral biology in humans

Remote ischemic preconditioning (RIPC) results in a powerful and widespread protective effect against subsequent prolonged ischemia-reperfusion (IR) injury of distant organs and systemic inflammatory responses, both of which are key elements in the evolution of local and multiorgan effects of many clinical IR syndromes. The signal transduction within the target organ to generate ischemia tolerance, and the effects of RIPC on systemic anti-inflammatory pathways, however, remain to be elucidated fully. Particularly, data regarding the mechanisms of 'second window' protection (a resurgence of protection 24-72 hrs after the initial RIPC stimulus) is scant; even less is known of the effects of repeated RIPC, and a potential 'third window' of protection. Our preliminary data and several recent publications have shown that the biology of RIPC and exercise show considerable overlap. This research has raised the possibility of a reciprocal effect between RIPC and exercise, with chronic exercise being a model of the potential effects of 'chronic preconditioning'. This is relevant, as repeated RIPC might be a strategy to improve exercise function in those with limited exercise tolerance e.g. heart failure.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years,
2. Informed consent

Exclusion Criteria:

1. Contraindication to exercise,
2. Vigorous aerobic/anaerobic exercise in duration of ≥15 minutes during the 21 days prior to commencement of the study, or either of the RIPC or exercise protocol arms,
3. Overt viral or bacterial infection in the 10 days prior to commencement of the study, or during either of the RIPC or exercise protocol arms,
4. Alcohol and/or caffeine consumption in the 10 days prior to, or at any time during the study period
5. Pregnancy
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder

The primary purpose of this study is to test the safety and tolerability of single ascending doses of Desvenlafaxine Succinate Sustained-Release (DVS SR) in both child and adolescent outpatients with major depressive disorder. This study will also characterize the pharmacokinetic profile of DVS SR in children and adolescents with major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatient between 7 and 17 years of age at baseline who meet Diagnostic and Statistic Manual of Mental Disorders, Fourth Edition, Text Revision criteria for major depressive disorder.
* Children's Depression Rating Scale --Revised (CDRS-R) score greater than 40 at the screening and study day -1 (baseline) visits and Clinical Global Impressions Scale--Severity (CGI-S) score of greater than or equal to 4 at the screening and study day -1 (baseline) visits.
* Depression of at least moderate severity with symptoms for at least 1 month before screening and that could, in the investigator's opinion, respond to therapy with antidepressant(s) alone (without concomitant psychotherapy).
* Other inclusion criteria apply.

Exclusion Criteria:

* History or current evidence of a medical condition known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs; history or presence of any other medical condition that might confound the study or put the study participant at greater risk during participation; known hypersensitivity to venlafaxine.
* History of suicide attempt or gesture in which the intent was suicide or serious self-harm or acute suicidality to such a degree that precaution against suicide must be exercised.
* Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a diagnosis of bipolar disorder or psychotic disorder or current (within 12 months before baseline) generalized anxiety disorder, panic disorder, social anxiety disorder, or attention deficit hyperactivity disorder (ADHD) if considered by the investigator to be primary (causing a higher degree of distress or impairment than MDD) or presence (within 12 months before baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, or narcissistic) as assessed during the psychiatric evaluations or history or presence of MDD with psychotic features.
* Other exclusion criteria apply.