cyrilzakka/clinical-trials huggingface dataset:
Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW)

There are no guidelines on the first maintenance daily dose of antiepileptic drugs (AEDs) in newly diagnosed, previously untreated epilepsy. Original trials and Cochrane reviews show that seizure remission can be achieved with differing daily doses. In clinical practice, the first maintenance dose varies significantly. In contrast, the risk of adverse treatment effects increases with dosage. There is thus the need to identify the lowest effective dose for treatment start. This background prompted us to undertake a randomized multicenter pragmatic non-inferiority trial comparing standard to low daily doses of AEDs to demonstrate that low doses are at least as effective as standard doses (as indicated by the national formulary) but are better tolerated and are associated with a better quality of life. If proven as effective as the standard dose, a low daily dose of AEDs is a benefit to the patient in terms of tolerability and safety and a source of savings for the National Health System.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older;
2. Newly diagnosed previously untreated epilepsy, defined according to the ILAE definition (Fisher et al, 2014);
3. Having experienced focal seizures, defined according to the ILAE criteria (Commission, 1981);
4. Able to understand and comply with the study requirements and release a written informed consent.

Exclusion Criteria:

A patient will be excluded if at least one of the following criteria will be met:

1. Age less than 18 years;
2. Having experienced primarily or secondarily generalized tonic and/or clonic seizures, or other (non-focal) seizure types;
3. Previous exposure to AEDs;
4. Requiring low or standard doses on account of individual needs;
5. Inability to understand the aims or modalities of the study;
6. Current pregnancy or planning to become pregnant during the study period (e.g. who are not post-menopausal, surgically sterile, or using inadequate birth control). A postmenopausal state is defined as no menses for 12 months without an alternative medical cause;
7. Previous treatment with an antiepileptic drug;
8. Men unable to practice contraception for the duration of the treatment.
9. Poor compliance with assigned treatments;
10. Refusal to release written informed consent;
11. The study investigators will receive the summary of product characteristics (SPC) available for each study drug. Patients cannot be enrolled in the study if the contraindications/warnings described in the SPC are met.
Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets

The main objective of this study was to investigate the relation between ceramic brackets and the development of white spot lesions (WSLs) compared to that associated with conventional metal brackets.

Objectives : The main objective of this study was to investigate the relation between ceramic brackets and the development of WSL compared to that associated with conventional metal brackets.

Study design: Randomized 2-parallel arm clinical trial. Materials and methods: Quantitative light induced fluorescence (QLF) images were taken for the two randomly allocated groups (Ceramic group, n=26; Metal group, n=25) of patients at T0: before the start of treatment; T1: after 2 months and T2: at 4 months after treatment). The QLF images were analyzed; Primary outcome measures: The lesion area (Pixels) and Mean amount of fluorescence loss (∆F)% and the number of newly developed lesions. Secondary outcome: Maximum fluorescence loss (∆F-Max)% and plaque surface area (∆R 30)%. Means and standard deviations for all the measured parameters at T0, T1 and T2 were calculated. Split plot analysis of variance (SPANOVA) test was used to determine the changes within each group at the different time intervals, and between the two groups. Chi square was used to compare between the two groups regarding the number of new lesions during the treatment. P value was set at 0.05 level.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects seeking orthodontic treatment with mild-to-moderate crowding (not exceeding 5 mm)
* No previous orthodontic treatment
* Optimum oral hygiene
* Maximum of 3 restored teeth
* Absence of defective enamel formation in the form of hypocalcification or hypoplasia.

Exclusion Criteria:

* Subjects with poor oral hygiene
* Defective enamel
* Patients with syndromes and Oro-facial anomalies or salivary glands diseases
Multimodal High-frequency Ultrasound-based Study of Plaque Psoriasis Severity Index

Psoriasis (PsO) is a common chronic relapsing inflammatory disease, induced by a combination of genetic and environmental effects, which seriously affects the quality of life of patients.Psoriasis Area and Severity Index（PASI score ） ，as the most common method used by clinicians to assess the severity of psoriasis and the effectiveness of treatment, has the disadvantage of being subjective and superficial.We are therefore committed to establishing an objective, real-time, repeatable, non-invasive, microscopic assessment using high-frequency ultrasound. This study will use high-frequency ultrasound to detect the patient's lesion site and the 2cm site next to the lesion once, and the study will continue to recruit for 6 months.

High-frequency ultrasound (HFUS) with a center frequency of more than 10 MHz, and a resolution of 16-158 μm. The detailed detection items are epidermal thickness (unit mm), dermal thickness (unit mm), hypoechoic cord thickness between epidermis and dermis (unit mm), epidermal echo intensity, dermal echo intensity, clarity of the boundary between dermis and subcutaneous tissue detected by Grayscale ultrasound; blood flow signal (pcs) detected by Color Doppler imaging and Power doppler imaging. The 8 tests will be detected the skin lesions and 2cm beside skin lesions area.Based on the correlation between the 8 indexes and local PASI scores, we will establish a model for the evaluation of psoriasis by multimodal high-frequency ultrasound.This study will use high-frequency ultrasound to detect the patient's lesion site and the 2cm site next to the lesion once, and the study will continue to recruit for 6 months

Eligibility Criteria:
Inclusion Criteria:

1. Patients who meet the medical criteria for plaque psoriasis
2. Those who voluntarily participate in this study and sign the informed consent form

Exclusion Criteria:

1. Patients with other types of psoriasis
2. Those with other active medical conditions that may affect assessment
3. During a severe uncontrollable acute or chronic local or systemic infection
4. Those with severe mental illness, cognitive impairment, and incapacity for personal behavior that makes them unsuitable to participate in a clinical study
5. Other reasons the investigator considers unsuitable for participation in this study
Effect of Aromatherapy on Pain, Anxiety and Sleep Quality in Burn Patients

This study, which was designed as a randomized placebo-controlled experimental study, was conducted to determine the effect of inhalation aromatherapy with lavender essential oil on pain, anxiety and sleep quality in burn patients.

After 5 patients were included in the sample size of the study, intervention and control groups, power analysis was performed using the G\*Power Software (3.1.9.2) program. With a margin of error of 5%, an effect size of 0.15, and a power of 95%, the sample group size was calculated as 54 patients. Considering that data loss might be 10% on average in the study, it was decided to recruit 60 patients. Participants were randomized according to patient rooms. There are a total of 11 rooms and 16 beds in the burn unit, 5 double and 6 single. 11 rooms are numbered sequentially according to their location in the corridor.

In the intervention group, seven drops of lavender essential oil were dripped onto a 5x5 gauze pad in the morning and evening, for 20 minutes, 10 cm away from the nose, and sniffed.

In the placebo control group, seven drops of saline/sterile water were dripped onto a 5x5 gauze pad in the morning and evening, and they were put to sniff for 20 minutes, 10 cm away from the nose. Green food coloring was added (one drop of food coloring to 5 ml of sterile/saline water) to make sterile/saline water similar to lavender oil. Data were collected using Individual Data Collection Form, Spielberg State Anxiety Scale, Visual Analog Scale, Richard Campbell Sleep Scale before and after five days of morning and evening aromatherapy application.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-65,
* 2nd and/or 3rd degree burns but not in emergency/resuscitative phase,
* Total body burn area is 5-30%,
* No acute-chronic respiratory system disease (asthma, COPD, etc.),
* No problem in sense of smell,
* No communication problem,
* Not participating in another study at the same time,
* Patients who volunteered to participate in the study.

Exclusion Criteria:

* Those who are allergic to lavender essential oil,
* Having a history of head trauma or convulsions,
* Having respiratory tract (inhalation) burn,
* Having alcohol or narcotic substance addiction,
* Having a history of pregnancy, epilepsy, high blood pressure and migraine,
* Patients undergoing intubation.
Effectiveness Study of the BOA(R)-Constricting IV Band

The purpose of this study is to determine whether the BOA(R)-Constricting IV Band is superior to standard methods for starting an IV.

We will test the hypothesis that paramedics and nurses treating in- and out-of-hospital patients with a BOA(R)-Constricting IV Band, compared to paramedics using standard treatment, will have better success rates for peripheral IV access.

Eligibility Criteria:
Inclusion Criteria:

* Paramedics employed by the City of Houston or nurses employed by Memorial Hermann Hospital - Texas Medical Center
* Agree to participate through written consent process

Exclusion Criteria:

* City of Houston paramedics and Memorial Hermann Hospital - Texas Medical Center nurses who do not provide written informed consent to participate
Assessment of a Proposed Microbiological Alert and Its Impact on a Sepsis Campaign

The aim of the present study was to evaluate the ability of health-care professionals in addressing sepsis, and the impact of a telephone call upon receival of blood cultures in the clinical microbiology department, from a clinical microbiologist, in the early management of sepsis.

Sepsis is one of the major challenges of modern medicine. It is an important health problem with a high incidence, morbidity and mortality that affects population worldwide. Without an early recognition and a prompt management, patients can develop more severe stages of the disease and even death. An appropriate and aggressive management can significantly improve outcomes. Thus, it is necessary to develop early warning systems of sepsis in the hospital.

In recent years, several campaigns and guidelines have been developed to help health care professionals in the management of sepsis. However, these have mainly focused on management protocols for severe sepsis and septic shock in intensive care units or emergency departments. To the best of the investigators knowledge, none of these have examined in depth either the impact of a sepsis alert system in general wards, nor the impact of a telephone call from a specialist in Clinical Microbiology, upon blood culture request, in the early recognition of sepsis.

The aim of the present study was to evaluate the ability of health-care professionals in addressing sepsis, and the impact of a telephone call upon receival of blood cultures in the clinical microbiology department, from a clinical microbiologist, in the early management of sepsis.

For this, the investigators performed a prospective study based on telephone calls followed by a phone interview to physicians and nurses in charge of patients whose blood cultures had just been received at the clinical microbiology department in a tertiary hospital.

Eligibility Criteria:
In-patients with blood cultures drawn and sent to the Microbiology laboratory, regardless of patient allocation (eg., emergency department, intensive care units, general wards)

Opportunity sampling: patients whose clinical history number ended in odd numbers were assigned to group A (intervention) and patients whose clinical history number ended in even numbers were assigned to group B (no intervention, control group).

Inclusion Criteria:

* Patients who had blood cultures drawn and sent to the Microbiology Laboratory, during the morning shift (from 9 am to 3 pm, Monday to Friday)
* Patients \>/=18 years old

Exclusion Criteria:

* Patients \<18 years old
* Patients with a recent bacteremic episode with no subsequent negative blood cultures
* In-patients with blood cultures drawn to whom the telephone call had already been performed.
Hetrombopag in Promoting Platelet Engraftment After Auto-HSCT in Children with Neuroblastoma

The goal of this clinical trial is to learn if hetrombopag promotes platelet engraftment in neuroblastoma children undergoing autologous hematopoietic stem cell transplantation. The main question it aims to answer is:

· Does drug hetrombopag promote platelet engraftment? Participants will take hetrombopag every day for 6 weeks or until platelet \&gt; 100\*10\^9/L.


Eligibility Criteria:
Inclusion Criteria:

* Age\<18 years old;
* Diagnosed as neuroblastoma;
* ECOG ≤ 2;
* First time receiving autologous hematopoietic stem cell transplantation;
* The subjects or their legal guardians agree to participate and sign the informed consent form.

Exclusion Criteria:

* ALT/AST \> 3 ULN, or TBIL \> 1.5 ULN;
* Have experienced congestive heart failure, arrhythmia, peripheral arteriovenous thrombosis requiring medication treatment within one year prior to enrollment, or have experienced myocardial infarction or cerebral infarction within three months prior to enrollment;
* Suffering from thromboembolic diseases;
* Other situations that are not suitable for inclusion in the study determined by researchers.
Reboxetine and Citalopram as an Adjunct Treatment to Second Generation Antipsychotics in the Treatment of Negative Symptoms of Schizophrenia

Main objective: To assess the efficacy of two antidepressants of different pharmacological families: citalopram (Selective serotonin reuptake inhibitors, SSRI) and reboxetine (Norepinephrine Reuptake inhibitor, NRI) as adjunct treatments to risperidone and olanzapine for the treatment of negative symptoms of schizophrenia.

Secondary objectives: To assess the efficacy of citalopram and reboxetine as adjunct treatments to risperidone and olanzapine for the treatment of cognitive symptoms of schizophrenia. To compare the efficacy of reboxetine and citalopram as adjunct treatments for the treatment of negative and cognitive symptoms of schizophrenia.

Method: Multicentric, randomized double-blind clinical trial compared to placebo with a six months follow-up. A total of 249 patients with a diagnosis of schizophrenia (DSM-IV criteria) and significant negative symptoms, will be recruited in the 9 participating centres. Variables: sociodemographic and clinical variables (PANSS, SANS, CGI global, GAF,LSP, Hamilton scale, BACS)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia (DSM-IV criteria)
* Stable doses of antipsychotic medication (olanzapine, risperidone)for at least 60 days prior to study initiation
* Presence of significant negative symptoms (defined as one or more negative symptom score grater than 4 in the PANSS scale) (Kay 1987)
* Patients have to give written informed consent to participate in the study

Exclusion Criteria:

* Patients with a substance abuse/dependence diagnosis in the previous six months.
* Mental Retardation.
* Patients taking antidepressant in the last 4 months before the trial.
* Patients taking other antipsychotic medication, except: sinquan 100, Entumine 40, Largactil 100 and Seroquel 200.
* Patients who score more than 20 in Hamilton Rating Scale for Depression.
* Pregnancy or lactation.
* Serious impaired kidney function.
* History of hemorrhagic disorders.
* Reboxetine or citalopram allergy.
Women at Risk of Breast Cancer and OLFM4

Does the olfactomédine provide an help to limit the number of false positives in the overall imaging balance and limit the number of unnecessary biopsies?

About 5% of breast cancers are associated with the presence of a constitutional genetic alteration. Two genes are being studied: BRCA1 and BRCA2.

The national program for breast cancer screening target women 50 to 74 years but does not include women with significant risk factors. However in identifiable risk situations, breast cancer incidence is increased: and it affects 1 in 4 women with certain risk histological lesions and more than 1 in 2 women carrying a mutation in the BRCA1 or BRCA2 gene.

Studies have shown that the olfactomédine 4 (OLFM4) is highly overexpressed in tumors compared to healthy tissue. The OLFM4 might therefore be a marker for early detection of breast cancer. We wish to determine the positive predictive value of OLFM4 seric dosing of patients at risk with respect to imaging.

Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years
* High risk women of breast cancer occurrence defined by the following criteria:

  * Women carrying a genetic mutation BRCA1 or 2 or TP53, entering or already in screening breast IRM
  * Women with a high probability of hereditary predisposition to breast cancer (20% risk at 70 years of breast cancer by BOADICEA model), assessed by the onco-geneticists
* Information of the person and signing the informed consent

Exclusion Criteria:

* Women with a history of breast cancer or in situ
* Person who is not affiliated to a social security scheme or beneficiary of such a regime
MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients

The aims of this study will be to evaluate the effect of motivational interviewing (MI) to improve self-care in heart failure (HF) patients and caregiver contributions to HF self-care. Also this study will evaluate the effect of MI on the following secondary outcomes: In HF patients: HF somatic symptom perception, generic and specific quality of life, anxiety and depression, sleep quality, mutuality with caregiver, hospitalizations, use of emergency services, and mortality; In caregivers: generic quality of life, anxiety and depression, mutuality with patient, preparedness, social support and sleep quality.


Eligibility Criteria:
Inclusion criteria:

Diagnosis of HF (for patient), New York Heart Association (NYHA) functional class II- IV (for patient), Inadequate self-care assessed with the Self-Care Heart Failure Index (for patient), Being the informal caregiver of the patients (for caregiver).

Exclusion criteria:

Severe cognitive impairment evaluated with the Six-item screener (for patient), Acute coronary syndrome during the last three months (for patient), Living in a residential settings (e.g., nursing home) (for patient), Patients not willing to participate in the study (for caregiver).
Yoga Effects on Heart Rate Variability and Electroencephalography

Since yoga breathing exercises are traditionally used to tranquilize the mind, and have a well-known positive effect on the cardiovascular system, it is our hypothesis that a respiratory yoga exercise named bhastrika pranayama may have positive effects on heart rate variability, electroencephalography, quality of life and salivary cortisol (stress hormone).

The effects of yoga interventions on heart rate variability have been previously shown in our laboratory, having its efficacy in improving autonomic heart modulation of hypertensives and elderly subjets proven. However, there is a lack of data addressing the effects of such interventions on EEG patterns of health fit male subjects, as well as there are no study investigating if there is a relationship between heart autonomic modulation changes and EEG patterns. Thus, the aim of this study was to investigate the effects of 1 month respiratory yoga training on heart rate variability, EEG, salivary cortisol and quality of life of health fit male subjets.

Eligibility Criteria:
Inclusion Criteria:

* Young adults;
* Physically fit (engaged in physical activity at least 2-3 times a week);
* Non athletes;
* Possibility to follow protocol agenda.

Exclusion Criteria:

* Epileptic events in previous 5 years;
* Chronic allergic rhinitis, with airway occlusion;
* Oral bronchodilator usage;
* Beta blocker user;
* Any diagnosed cardiac rhythm alteration at rest;
* Cerebral dysrhythmia;
* Previous training in respiratory yoga exercises.
Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus

This study evaluates the use of topical cyclosporine 0.05% and sodium carboxymethylcellulose 0.5% for the treatment of dry eye disease in patients infected with the human immunodeficiency virus.

Twenty HIV-positive-patients were selected from the Department of Infectious Diseases of the Federal University of Rio de Janeiro Hospital. Dry eye diagnosis was based on a dry eye questionnaire (Ocular Surface Disease Index - OSDI®), Schirmer I Test, break up time and 1% rose bengal staining of the ocular surface. The patients were divided into two groups with ten patients. Group I received sodium carboxymethylcellulose 0.5% drops and group II received sodium carboxymethylcellulose 0,5% drops and topical cyclosporine 0.05% for six months.


Eligibility Criteria:
Inclusion Criteria:

* HIV seropositivity
* Dry eye diagnosis

Exclusion Criteria:

* Hepatitis B infection
* Hepatitis C infection
* Menopause
* Rheumatic diseases
* Contact lens wear
* Beta-blocker eye drops
* Blepharitis
* Use of medications associated with dry eye (diuretics, antidepressive agents, beta-blockers)
Reducing Transphobia Among Adolescents Through a Brief Video Intervention

The purposes of this new study are to test among adolescent viewers the utility of brief video-based interventions to:

1. reduce transphobia;
2. reduce depression-related stigma and increase likelihood of treatment-seeking; and
3. examine the role of viewer's sex (male / female / non-binary), race (Black vs non-Black), and sexual orientation (straight vs LGBQ) as independent factors on the outcomes of interest.

Intervention videos will each be of \~100-second duration and feature four underage professionals (ages 16) acting as simulated patients. All videos will focus on an empowered presenter with depression sharing their personal story regarding depression. They will describe how social supports from family, friends, and community, as well as professional help assisted them in overcoming symptoms of the illness, as well as how being transgender may have had an impact on it. The four actors will include two males (one trans, one cis) and tow females (one trans, one cis).

Assessments will occur at baseline and post-intervention, and will include:

1. Demographics (baseline only);
2. Primary outcome:

   a. Attitudes toward Transgender Men and Women (ATTMW) scale.
3. Secondary outcome:

   1. Transgender attitudes: feelings thermometer, modeled after Norton et al 2013.
   2. Depression-related stigma (Depression Stigma Scale \[DSS\]);and
   3. Help-seeking (General Help-Seeking Questionnaire \[GHSQ\]).

For each of study we intend to randomly assign \~1,000 individuals aged 14-18 as follows:

Randomized, in equal proportions, and stratified by sex and race, to view one of four \~100-second videos:

1. Transgender male;
2. Cis-gender male);
3. Transgender female;
4. Cis-gender female.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Living in the US
* Ages 14 - 18

Exclusion Criteria:

* None