cyrilzakka/clinical-trials huggingface dataset:
A Study of the Effect of Time on Topical Anesthetic Efficacy.

This is a study of the effect of time on the effectiveness of topical anesthetics in the mouth. The Null Hypothesis is: Regardless of the time of application over a 10-minute period, there is no difference in the clinical effectiveness of the topical anesthetic 5% lidocaine on (a) the pain of needle stick insertion and (b) the pain of local anaesthetic administration.

The study design will be a double blind randomized controlled split-mouth clinical trial. It is proposed to compare the effectiveness of the standard topical anesthetic 5% lidocaine with a placebo over the time period of 2, 5 and 10 minutes after application. The topical will be placed on the palatal soft tissue where the perception of pain is the highest in the oral cavity. Both the pain of needle insertion and the pain of local anesthetic injection will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. In good health (ASA 1 or ASA 2)
2. Weight between 40-100kg, inclusive.
3. Between ages 18-70, inclusive.
4. Informed consent

Exclusion Criteria:

1. ASA 3 or higher.
2. History of allergy to sulfites, lidocaine or mepivacaine.
3. Taking any analgesic 48hrs before testing, such as an NSAID, opioid, or acetaminophen.
4. Pregnancy.
5. Recent oral trauma.
6. Lack of informed consent.
Relationship Between Central Sensitization Symptoms and Cognitive Dysfunction in Fibromyalgia.

The aim of the study is to investigate the relationship between central sensitization parameters and cognitive dysfunction in patients with fibromyalgia.The main questions it aims to answer are:

Do central sensitization symptoms affect cognitive dysfunction in patients with fibromyalgia? To what extent do central sensitization symptoms affect objective and subjective cognitive complaints in fibromyalgia patients? How do cognitive complaints relate to other clinical parameters, including disease severity, in these patients?

Central sensitization is defined as an increase in pain sensitivity with amplification of neuron-derived signals in the central nervous system. Fibromyalgia is a disease characterized by chronic widespread pain, and although its etiology and pathophysiology are still not fully known, it is considered a major member of the group of diseases known as central sensitivity syndromes, which progress with impaired pain regulation.

Fibromyalgia negatively affects the patient's functionality in various ways. One of these is cognitive dysfunction, and previous studies have shown that fibromyalgia patients experience significant deterioration in all parameters related to cognitive function compared to healthy controls. Central sensitization has been shown to be associated with comorbidities such as depression, anxiety, sleep disorders and fatigue in many disease groups, including fibromyalgia, and data on its effect on cognitive dysfunction are limited.

A study found that impaired conditioned pain modulation, one of the methods used in the evaluation of central sensitization in fibromyalgia patients, was associated with cognitive dysfunction.In addition, cognitive impairment in these patients is associated with a decrease in the quality of life of the patients and is suggested to be one of the important clinical findings of the disease. Considering all these data, it seems likely that central sensitization negatively affects cognitive function in fibromyalgia, and this study aimed to examine in detail the relationship between central sensitization and cognitive dysfunction in fibromyalgia patients.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with fibromyalgia according to American College of Rheumatology 2016 criteria
* Being between 18-65 years old
* Being literate
* Accepting to participate in the study

Exclusion Criteria:

* Concomitant systemic inflammatory disease, central nervous system disease (cortical involvement), active infection and malignancy history
* History of illness that may lead to cognitive impairment
* Being \<18 and \>65 years old
* Being illiterate
* Not accepting to participate in the study
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at three weeks post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).


Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant females and aged ≥ 18 years;
* Willing and able to adhere to visit schedules and all study requirements;
* Subjects read and signed the study-specific informed consent.

Exclusion Criteria:

-
Serum CXCL10 and CRP Levels in Patients with Acne Vulgaris in Correlation with Disease Severity

the correlations between CXCL10 levels, CRP, and acne severity scores (e.g., Global Acne Grading System) suggest that CXCL10 could serve as a biomarker of inflammation and acne severity. Understanding the relationship between CXCL10, CRP, and acne severity may offer insights into novel therapeutic strategies targeting inflammatory pathways in acne.

Cross-sectional Observational Study. using 4 groups a 3 of different acne severity and controle one . the serum cxcl10 and crp will measured in each patient to correlate with disease severity

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 12-40 years diagnosed with acne vulgaris.
2. Both genders included.
3. Patients with mild, moderate, or severe acne severity as determined by a validated scoring system (e.g., Global Acne Grading System).
4. Patients not on systemic acne treatment (e.g., isotretinoin or antibiotics) or anti-inflammatory drugs.

Exclusion Criteria:

1. Patients with autoimmune diseases, systemic illnesses, acute infection or any other chronic inflammatory conditions that may affect CRP or CXCL10 levels.
2. Pregnant or lactating individuals.
Examining the Impact of Behavior Change Intervention

The health-related benefits of physical activity are well established for all age groups. It also has positive effects on memory, executive function and school performance in children and adolescents. However, it is known that 81% of individuals between the ages of 11-17 live a life that is not physically active enough. The World Health Organization recommends interventions to increase physical activity. In this study, 48 students from 5th, 6th and 7th grades will be selected from randomly selected secondary schools in Karaman central district and will be divided into experimental and control groups. In this randomized controlled study, behavior change intervention with the 5A model will be applied to the experimental group, and no intervention will be applied to the control group. Physical activity levels, physical and psychosocial health of children in both groups will be evaluated at the beginning of the intervention, at Week 8 and at Week 28. Physical activity diary, "Physical activity scale for 4-8 Grades" scale will be used to measure children's physical activity levels. For their physical health, body composition, strength, flexibility and functional capacity will be evaluated. Quality of life with the "Pediatric Quality of Life 4.0 Inventory" for psychosocial health; Cognitive functions will be evaluated with "CNS Vital Signs Cognitive Performance and Attention Tests". This study aims to evaluate the sustainability effect of the 5A intervention on physical activity and its impact on physical health and psychosocial health.

Behavioral interventions for health promotion are widely used for preventive health practices. There are many studies on topics such as smoking, diet, obesity and oral care. However, we see that studies improving physical activity behavior in children are limited. Considering that physical activity is an important health-related behavior that should be acquired from childhood, we predict that studies on this subject will have an important place in the literature. In addition, it is stated in the guidelines that while the effect of physical activity behavior on health-related parameters in children is clear, more evidence is still needed on its effect on cognitive functions. With our study, we aim to examine the sustainability, physical and psychosocial effects of developing physical activity behavior in children using the 5A model and contribute to the literature.

Eligibility Criteria:
Inclusion Criteria:

* Being a middle school student
* Being between the ages of 10-12
* Getting \<3.16 points from the "Physical activity scale for grades 4-8"

Exclusion Criteria:

* Having a condition where exercise is contraindicated
* Families or children do not give consent to participate in the study.
* Having a psychosocial problem that prevents adaptation to work
Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus Steroid

The purpose of this study is: To explore the potential role of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy.

To investigate the safety and tolerability of Tripterygium wilfordii plus steroid

Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with tacrolimus plus steroid in patients with nephrotic syndrome including patients with membranous nephropathy. This study will evaluate the safety and effectiveness of a traditional herbal extraction, Tripterygium wilfordii, plus steroid in reducing the amount of protein in the urine in patients with membranous nephropathy. A hundred patients with biopsy-proven membranous nephropathy will be recruited. They will be screened with a medical history, physical examination, blood tests, and an examination for infection, cancers, and other conditions that can cause membranous nephropathy. The investigators plan to conduct an open-label study of the efficacy and safety of Tripterygium wilfordii in the treatment of membranous nephropathy. Half of them will be treated with oral Tripterygium wilfordii plus steroids for 6 months, followed by 6 months of maintenance, and the other half treated with tacrolimus plus steroid as positive contrast. Proteinuria, renal function will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.4 mg/day and serum albumin\>35g/L. This study will explore the potential role of Tripterygium wilfordii in the treatment of membranous nephropathy, it's cost less .

Eligibility Criteria:
Inclusion Criteria:

1. Biopsy-proven idiopathic membranous nephropathy
2. Nephrotic syndrome with proteinuria ( \> 3.5 g/day) and serum albumin \< 30 g/dl
3. Age 18-65 years with informed consent

Exclusion Criteria:

1. Patient with elevated serum creatinine concentration
2. Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days
3. Active/serious infection
4. Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
5. Patient who is diabetic
6. Patient is allergic or intolerant to macrolide antibiotics or tacrolimus
Survival Endpoints for Treatment Evaluation in Subjects Treated for Metastatic Breast Cancer: Contribution of Real-life Databases

Overall survival (OS) is considered the most reliable cancer endpoint and used by the Health Rregulatory authorities (HRA). OS presents multiple advantages in cancer randomized controlled trials (RCT): it is universally accepted as a measure of clinical benefit for the patient; it is objectively defined, both in terms of events and date of incidence; it is easily and precisely measured and thus reproducible; it can be exhaustively collected. As such, OS has been validated by HRAs. On the other hand, OS presents some limitations. Observing a benefit on OS may require a large number of patients and/or considerable time for patient follow-up. Costs for trials may be increased, and there might be delays in the introduction of possible beneficial treatments for patients. The development of alternative endpoints that could capture treatment benefit appropriately and be measurable earlier, is central for the evolution of clinical research in oncology.

Real world data (RWD) are defined as other sources than clinical trials such as: electronic medical records, registries, insurance claims, pharmacy records, death certificates and other patient-generated data.

This research is aimed at (i) describing the existing endpoints of survival in real-life setting, (ii) comparing the correlation at individual level with data to clinical trials for related to anti-HER2 targeted therapies and endocrine therapies in MBC. We will investigate the individual correlation between candidate surrogate endpoints and overall survival in a population-based record-computerized database centralizing data on about 20,000 patients from 2008 to 2017 in France.

This work should lead to the estimation of various time-to event endpoints (e.g. OS, PFS, etc), in the real-life setting, for mBC patients. In addition, we will estimate their individual correlation with OS, which should help us highlight potential surrogate endpoints in this setting. We will focuss on three distinct population, accounting for a large population of mBS patients: : patients treated with anti-HER2 targeted agents, patients treated with endocrine therapies and elderly population.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic breast cancer

Exclusion Criteria:

* Individual patient data unavailable
Retrospective Analysis of Clinical Features in Ventriculoperitoneal Shunt Infectionsin Adults

The objectives of this study are:

* To describe the incidence of clinical features in adults with internal ventriculoperitoneal (VP) shunt infections,
* To determine the validity of laboratory parameters in adults with internal ventriculoperitoneal shunt infections and
* To evaluate the relationship between the timing of shunt re-implantation with the rates of relapse and secondary infection.

Information from medical records of patients seen by the PI will be collected and analyzed to describe the incidence of clinical features in adults with internal ventriculoperitoneal shunt infections, to determine the validity of laboratory parameters in adults with internal ventriculoperitoneal shunt infections and to evaluate the relationship between the timing of shunt re-implantation with the rates of relapse and secondary infection.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age \>= 18 yrs) with VP shunts (ventriculoatrial \[VA\], and other cerebrospinal fluid \[CSF\] catheters will not be included).
* Cases will include patients with a diagnosis of VP shunt infection.
* Controls will be patients with a clinical suspicion of shunt infections with negative CSF cultures.

Exclusion Criteria:

* Patients with meningitis from community acquired organisms (e.g. Streptococcus pneumoniae, Neisseria meningitidis, Listeria monocytogenes and Haemophilus Influenzae).
Intralesional Injections of Triamcinolone for Acne Vulgaris

This proof-of-concept study seeks to investigate the safety of intralesional injections of triamcinolone for acne vulgaris lesions using an Intradermal Needle Adapter.

This is an open-label, prospective, single-arm study. Approximately 20 subjects will be enrolled at 1 study site.

All subjects will receive treatment with the study protocol (i.e., intralesional injection with triamcinolone) at Visit 1 (Day 1). Subjects will then attend in-clinic visits at Visit 2 (24-hours post-injection), Visit 3 (48-hours post-injection), Visit 4 (72-hours post-injection), Visit 5 (Day 7), and Visit 6 (Day 14).

Efficacy assessments (target lesion assessments, photography) and safety assessments will be conducted by the Investigator at each study visit. Subjects will conduct lesion pain assessments at each study visit as well as satisfaction assessments at each post-treatment visit.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline.
* Diagnosed with facial acne vulgaris.
* At least one (1) identifiable inflammatory lesion that, in the opinion of the investigator, is amenable to intralesional injection of triamcinolone.
* Able to follow study instructions and likely to complete all required visits.
* In good general health as determined by medical history at the time of screening (Investigator discretion).
* Sign the IRB-approved informed consent form (including HIPAA authorization) prior to any study-related procedures being performed

Exclusion Criteria:

* Female subjects who are pregnant or breast-feeding.
* Known hypersensitivity or previous allergic reaction to any constituent of triamcinolone injection.
* Active cutaneous viral infection in any treatment area at Baseline.
* Have concomitant skin disease or infection (other than acne) or presence of skin comorbidities in the areas of skin where study device will be used.
* History of poor cooperation or unreliability (Investigator discretion).
* Planning to move out of the area prior to study completion.
* Subjects who are investigational site staff members or family members of such employees.
* Exposure to any other investigational /device within 30 days prior to Visit 1.
Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation

This is a Single arm clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT.

A dose escalation study evaluating the safety and efficacy of human amniotic epithelial cells( hAECs) in preventing acute graft-versus-host(aGVHD) disease after hematopoietic stem cell transplantation(HSCT). The doses were 1×10\^6、2×10\^6、5×\^6 cell/kg, successively.

Eligibility Criteria:
Inclusion Criteria:

* Standard risk GVHD patients with hematological malignancies;
* High risk GVHD patients with hematological malignancies: haplotype hematopoietic stem cell transplantation patients, donor is female or more than 30 years old;
* Well informed about this study and signed a consent form before the trial;
* Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion;
* No evidence of lung infection by X-rays examination;
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1, Hematopoietic cell transplantation - specific comorbidity index (HCT-CI) of 0, 1, 2;
* Normal liver and kidney function;

Exclusion Criteria:

* Reduce pretreatment dose or secondary transplantation;
* participate other clinical trials within 2 months before this study;
* Female, 1) pregnant/nursing period, or 2) have a pregnancy plan during the study period, or 3) have fertility and cannot take effective contraception;
* History of severe allergic disease or is allergic to one or more drugs;
* Patients who are considered unsuitable for the study by the investigator.
A Trial of RSL Versus WL for Malignant Breast Disease

The purpose of this randomized trial is to determine the superiority of utilizing radioactive seed localization (RSL) over wire-guided localization (WL) for palpable or non-palpable malignant lesions in patients undergoing breast conservation surgery (BCS).

Consented and eligible subjects will be randomized to either radioactive seed localization or wire localization and stratified by surgeon and invasive versus DCIS prior to localization. Subjects on both arms will undergo breast conservation surgery including surgical specimen removal. Specimens will be grossed according to standard of care procedures. Localization, breast conservation surgery, and post-operative appointments will follow standard of care guidelines. Surveys will be administered according to the study calendar to the radiologist, surgeon, pathologist, and subject for data collection.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 20 to 99 years of age
* Breast lesion necessitating image-guided excision
* Unifocal disease
* Breast-conservation candidate
* Biopsy-proven malignant breast lesion including by not limited to invasive ductal carcinoma, invasive lobular carcinoma, and ductal carcinoma in situ
* Signed written informed consent document by the subject and/or a LAR

Exclusion Criteria:

* Male
* Multifocal or multicentric disease
* Receiving neoadjuvant chemotherapy
* Pregnant or breastfeeding
* Locally advanced disease
* Breast conservation contraindication such as inability to receive whole breast radiation therapy, inability to tolerate localization procedure, inability to lay flat or prone for radiation, and undesirable tumor to breast ratio
* Prior breast cancer on ipsilateral side
* Unable or unwilling to adhere to post-localization instructions (e.g. timely seed removal)
Cumulative and Booster Effects of Multisession Prefrontal Transcranial Direct Current Stimulation in Adolescents with ASD

Autism spectrum disorder (ASD) is a pervasive and lifelong developmental disorder that currently affects 1 in 54 children. Individuals with autism are often severely impaired in communication, social skills, and cognitive functions. Particularly detrimental characteristics typical of ASD include the inability to relate to people and the display of repetitive stereotyped behaviors and uncontrollable temper outbursts over trivial changes in the environment, which often cause emotional stress for the children, their families, schools and neighborhood communities. To date, there is no cure for ASD, and the disorder remains a highly disabling condition. Recently, transcranial direct current stimulation (tDCS), a noninvasive neuromodulation technique, has shown great promise as an effective and cost-effective tool for reducing core symptoms, such as anxiety, aggression, impulsivity, and poor social communication, in patients with autism. Although the empirical findings in patients with ASD are encouraging, it remains to be determined whether these experimental data can be translated into real-world benefits. An important next step is to better understand the factors affecting the long-term efficacy of tDCS treatment - in particular, the possible risk factors associated with relapse in patients with ASD and the role of booster session tDCS as an add-on treatment to induce long-lasting neuroplastic effects in ASD.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who are confirmed by a clinical psychologist based on the Diagnostic and Statistical Manual of Mental Disorders-5th Ed (DSM-V) criteria of Autism spectrum disorder and structured interview with their parents or primary caregivers on their developmental history using the Autism Diagnostic Interview-Revised (ADI-R).
* Individuals with ASD who are comorbid with ADHD symptoms will be included if they were willing to abstain from the use of these medications at least 96 hours before the commencement, until the completion, of the treatment.
* In view of the fact that neuroadaptation to antipsychotics typically occurs within six months, potential participants who are prescribed antipsychotic medications will only be included if the dosage of the medication remained unchanged for six months or more before the experimental period.

Exclusion Criteria:

* Individuals without a confirmed diagnosis from the clinical psychologist, with a history of other neurological and psychiatric disorders and head trauma, or on psychiatric medication will be excluded from the study.
* In view of the possibility of seizure induction by tDCS, potential ASD participants comorbid with epilepsy will be excluded.
* Potential participants comorbid with mood or anxiety disorders will also be excluded.