cyrilzakka/clinical-trials huggingface dataset:
Single Dose of Clonazepam Versus Intermiittent Diazepam for Febrile Seizures Prevention

To study the efficacy and safety of single dose clonazepam compared with intermittent oral diazepam for prevention of recurrent febrile seizures in children who had three or more febrile seizures.

Febrile seizures are the most common type of seizures disorder of young children. The risk of recurrences are 33 percent overall, half of them had at least one recurrent seizure (the 3rd febrile seizures). After that the recurrent rate is 50-100 percent depend on their risk factors. A few studies found that multiple recurrent febrile seizures might associated with language developmental delayed, poor speed performance quotient, Attention deficit hyperactivity disorders. Moreover, seizures are upsetting both parents and children. During the febrile illness, the intermittent diazepam, continuous phenobarbital and valproate are effective for prevention of the recurrences. Because of the benign nature of a simple febrile seizures, the risks of side effects generally outweigh the benefits. However, there is no clinical guidelines for prevention of recurrent febrile seizures in the children who experienced multiple occurrences. The better prophylactic drug; safe, effective and easy to use, for prevention of recurrent febrile seizures in children with multiple recurrences might be needed. Clonazepam, the long half-life benzodiazepine, is commonly used for treatment of epilepsy may be effective in preventing recurrent febrile seizures. This study, a single-blind, randomized clinical trial, single dose clonazepam at the time of fever present compared with oral diazepam during the fever to prevent the recurrent febrile seizures.

Eligibility Criteria:
Inclusion Criteria:

* age 6-60 months at date of enrollment
* 3 or more episodes of clinically diagnosed febrile seizures

Exclusion Criteria:

* history of afebrile seizures or any history suggested the epilepsy
* history of previous brain insults; CNS infection, birth trauma, traumatic brain injury.
* delayed developmental milestones
* abnormal neurological examinations
* currently treatment by continous antiepileptic drug(s)
* A contraindication to Clonazepam, Diazepam such as drug hypersensitivity, liver disease.
* Predictable lack of available of follow up.
A Continuous, Non-Invasive, Real-time Method for Estimating and Predicting Intracranial Hypertension

There is statistically significant correlation between invasive measures of intracranial pressure (ICP) and non-invasive, real-time, continuous physiologic waveform data algorithms to predict ICP. Furthermore, characteristics within this physiologic waveform data will allow modeling for trend prediction of derived ICP information. Specific aims:

1. Develop models to estimate ICP and cerebral perfusion pressure (CPP) after traumatic brain injury in humans.
2. Predict and anticipate changes in ICP for preemptive management purposes.
3. Analyze characteristics of changes in ICP after treatment failure.
4. Analyze data to predict/anticipate confounding physiologic factors that affect ICP and its treatment.
5. Test the resulting models in real time.


Eligibility Criteria:
Inclusion Criteria:

* patients with severe traumatic brain injury resulting in motor Glasgow Coma Score (GCS) score \< 5
* age 18-89 years
* health care provider indicating the need for hyperosmolar therapy for elevated ICP

Exclusion Criteria:

* pregnancy
* incarceration
* brain death (GCS 3 with fixed, dilated pupils)
* life-threatening systemic injuries (Abbreviated Injury Scale (AIS) \>4 in an organ system other than CNS)
Clinical Assessment of Voriconazole Self Nano Emulsifying Drug Delivery System Intermediate Gel

Clinical study for the developed voriconazole self nano emulsifying drug delivery system intermediate gel was conducted on 30 patients with tinea versicolor infection.

The clinical work has been carried out in accordance with The Code of Ethics of the World Medical Association for experiments involving humans. The study was conducted on 30 patients (10 to 60 years old) with tinea versicolor attending the dermatology department outpatient clinic of Minia University Hospital. Local institutional review board approval was obtained for this study (ethical approval number is 24/18). Pregnant or lactating females and Immunocompromized patients. The patients were then divided into 3 groups, placebo group, group A and group B, consisting of 10 patients each. The placebo group received unmedicated formulation, Group A received the medicated formulation once daily and group B were treated twice daily. An informed consent has been obtained from all patients enrolled in the study for photography and treatment. History and general local examination were performed for all patients.The patients were clinically examined under normal light and using wood's lamp and cello-tape test was performed to confirm infection after determining the type of infection and in some cases scrapes were taken to detect infection in clinically indefinite cases and stained using potassium hydroxide 20% then examined for presence of fungal elements. Treatment was performed by applying the gel once or twice daily until full recovery was achieved with follow up once a week to reassess the condition. The clinical improvement of the patients, patient satisfaction and length of treatment were assessed. It was rated by both patient and physician as excellent, good, fair or poor according to the following criteria. Excellent: both the patient and the physician agreed that the result was satisfactory. Good: the result although acceptable was not quite up to expectations, but the physicians were pleased with the outcome. Fair: the improvement was evaluated by both the patient and the physician to be less than expected but still with some improvement. Poor: unsatisfactory results to the patient and /or the physician. All adverse effects were checked during study.High resolution digital photographs were taken for lesions of all patients using identical camera folder setting before starting treatment, on each follow up visit and after complete recovery. Clinical improvement was evaluated by physicians. The criteria for evaluations using a quartile grading scale were: 0=no improvement. 1=mild (percent improvement, less than 25%), 2=moderate (percent improvement 25-49%), 3=good (percent improvement 50-74%), 4=excellent (percent improvement equal to or more than 75%). In addition, a patient satisfaction score was rated using the following scale, A. satisfied, B.

Eligibility Criteria:
Inclusion Criteria:

* Tinea Versicolor infection

Exclusion Criteria:

* concomitant treatment with other medications for the same condition being studied, TVC.
* pregnancy
* lactation
* immunocompromised patients
Immunogenicity of Fractional Dose of the HPV Vaccines

This randomized phase IV trial compares intramuscular and intradermal fractional dose of bivalent HPV vaccine to fractional dose of nonavalent HPV vaccine among men and women aged 27-45 years in Seattle, Washington. Participants will have immune response assessed at baseline, 4 weeks, 6 months, and 12 months


Eligibility Criteria:
Inclusion Criteria:

* Age 27-45 years at enrollment
* Not intending to receive the HPV vaccine series for the duration of the study participation
* Willing and able to: provide written informed consent, undergo clinical evaluation, adhere to follow-up schedule

Exclusion Criteria:

* Prior immunization with HPV-vaccine (Cervarix, Gardasil-4, Gardasil-9)
* Currently pregnant or breastfeeding
* Immunedeficiency disease/condition or cancer that causes clinically significant immunosuppression
* Known HIV infection
* Chemotherapy (current or within 12 months) or currently taking a medication that causes clinically significant immunosuppression.
* Unstable medical condition (e.g., malignant hypertension, poorly controlled diabetes)
* Known allergy to vaccine components
* Prior history of HPV-associated cancer
* Any medical condition which, in the opinion of the investigator, may compromise the subject's ability to safely complete the study.
Put a Face to a Name (Part A): The Effects of Photographic Aids on Patient Satisfaction, Clinician Communication, and Quality of Care

Communication is critical within healthcare, and is the root cause of most errors. With increased adoption and use of new information technologies and mediated communication systems, such as Electronic Health Records (EHR), that support visual content, hospitals can begin to look at the potential of photographic aids to improve patient satisfaction, clinician communication, and ultimately quality of care. Having pictures of clinicians and patients may improve communication by improving knowledge of who is part of the care team and may reduce electronic ordering or documentation on the wrong patient.

Despite the importance of communication between clinicians and the many advances within information and communication technologies, there is a lack of literature documenting systems that are effective at improving communication. Our research study will provide an overview on the communication models and technologies used in Canadian hospitals and add insights to the impacts of these technological adoption.

Research Question: How does the use of photographic influence patients' hospital experience?

Specifically, do photographic aids (photographs of clinicians' faces) influence:

1. Patient's ability to identify their clinical care team members
2. Patient's ability to identify their care team members and know their individual roles
3. Patient's satisfaction with their hospital experience

The investigators will conduct interviews of a cross-sectional sample of patients for up to one year. There will be 2 visits during the study. The first visit should last for 15 minutes (to get consent), the second visit should last somewhere between 30 and 45 minutes. The research team created a structured survey tool designed to characterize patients' knowledge of the names and roles of their health care professionals and understanding of their plan of care, which includes some semi-structured questions to assess patient satisfaction with their hospital experience. This survey tool will be administered to participating patients each weekday during the study period, prior to their discharge from the hospital.

At the first visit, depending on whether the participant was previously assigned to group A, B or C, participants will be provided with a piece of paper listing the names of the members of their clinical care team (group B), or a piece of paper with a list of names and photographs of the members of their clinical care team (group C), or no paper at all (group A) which is currently the typical communication experience at the hospital.

There is no compensation for participation in the study.

Eligibility Criteria:
Inclusion Criteria:

* Must be admitted as an in-patient in the GIM ward at Toronto General Hospital.
* The ability of the patient to provide informed consent.

Exclusion Criteria:

* Patients with significant confusion, delirium or dementia will be screen by asking orientation to place and time.
Supplemental Adjuvants for Intracellular Nutrition and Treatment

Nutritional supplements have an augmentative effect on the outcomes of standard treatment of diabetic macular edema (DME) and Neovascular Age-Related Macular Degeneration (NAMD).

It has been shown that in chronic diseases, oxidative stress results from Nitric acid reacting with oxygen to form toxins that damage both somatic and mitochondrial DNA. The potential for protecting the DNA and promoting repair by using nutritional supplements will be tested by augmenting standard treatments for DME and NAMD with such supplements. The patients will be randomized to treatment group and placebo group and followed up for a year in a double masked fashion. Anatomic and visual outcomes, as well as side effects will be assessed and analyzed. If the results are promising, this pilot study can be used to design alternative (cheaper, better and longer lasting) treatments for DME, NAMD and perhaps other chronic illnesses.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of NAMD
* Clinical Diagnosis of DME

Exclusion Criteria:

* Pregnant Women
* Known allergy to any component used in the treatment combinations
Effectiveness of ResArgin on Adult's Body Composition and Health

The goal of this clinical trial is to learn if the supplement ResArgin (a reservatrol-based supplement) works to slow down muscle loss during a period of fat loss. Other related health outcomes such as sleep, mood, and activity will be assessed. The main questions it aims to answer are:

Does ResArgin improve muscle loss? Does ResArgin improve sleep quality, activity, mood, and body satisfaction.

Researchers will compare ResArgin to a placebo (a look-alike substance that contains no active ingredients) to see if ResArgin works to improve muscle loss and related health outcomes.

Participants will:

Take ResArgin or the Placebo every day for 3 months

Assessment will occur at Baseline, Day 30, Day 60, and Day 90.

Participants will complete a daily diary of their mood and health.

Study Purpose: Examine the effectiveness of ResArgin in attenuating muscle loss during a period of fat loss in overweight and mildly obese men and women.

Outcomes: Primary outcomes will be body composition. Secondary outcomes will be physical activity, food cravings, health-related quality of life, body satisfaction, basal metabolic rate, sleep behaviors, mood, anxiety, and perceived stress.

Study Design • Randomized double-blind placebo-controlled trial

o N = 60 men and women (30 adults in the ResArgin Condition and 30 adults in the Placebo Condition).

Eligibility Criteria:
Inclusion Criteria:

* overweight and mildly obese adults
* age range between 25 to 60 years

Exclusion Criteria:

* metabolic or endocrine related dysregulation including but not limited to: diagnosis of type I or type II diabetes, liver, kidney, or pancreatic dysfunction.
* history of seizures or epilepsy-related disorders
* musculoskeletal issues that would prohibit them from engaging in spontaneous activity,
* metabolic disorder
* sleep disorder
* psychiatric condition
* dietary aversions or restrictions including any animal sources of protein, dairy, fruits/vegetables, nut/seed allergy, eggs, and wheat/gluten or are currently following a carbohydrate restricted (under 20%) habitual diet.
* smokers
* consume excessive amounts of alcohol (\>3 drinks/d)
* actively intermittent fasting
* actively trying to lose weight or have lost more than ± 3kg in previous 3 months
* pregnant
* nursing
* trying to conceive
* changed their birth control in the past 3 months.
E3 Breast Cancer Taxotere Combination

To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology


Eligibility Criteria:
Inclusion Criteria:

* Females with histological/cytological confirmation of breast cancer.
* Subjects with a measurable lesion or bone lesions

Exclusion Criteria:

* Previous radiotherapy within 6 weeks
* Significant cardiac events, arrhythmias or other cardiac conditions
Comparing Telepractice and Conventional Face-to-face Voice Therapy

People over 55 years are high-risk with voice disorders. Voice disordered elderly need vocal training in order to improve communication efficiency and quality of life. However, participation in vocal training of elderly is often restricted by motivation, time of practice, and availability to hospital, which thus reduces treatment effects. The purpose of the study is to design a telecommunication vocal training system and a vocal training program for voice disordered elderly in Taiwan. The investigator proposed a 3-year consecutive study, including a single-blind, randomized controlled trial, to test the hypothesis that vocal training via telepractice for voice disordered elderly are not inferior to the standard face to face training.

Randomization: per mutated block, 40 patients on each arms (experimental and control)

Allocation: sealed envelope indicating either of the 2 groups

Intervention: weekly vocal training, each course last for 30-40 minutes,lasting for 2 months

Outcome measurement: before treatment, 1 month, 3 months, and 6 months after treatment

Primary outcome: 10-item voice handicap index

Secondary outcome: acoustics and aerodynamic parameter

Eligibility Criteria:
Inclusion criteria:

* patient equal or older than 55 years old
* Voice Handicap Index-10 (VHI-10) score \>10 point
* accessibility to a network connection

Exclusion criteria

* neurologic disorders
* active pulomanory disease
* mental disorder
Open Label Clinical Trial of Vitamin D in Children With Autism

Primary: to investigate tolerability of interventional high dose Vitamin D3 supplementation, titrated to reach serum levels near the high end of the reference range (30-100 ng/ml), in vitamin D deficient pediatric Autism Spectrum Disorder (ASD) patients.

The study will determine if initial safety and effect estimates predict that a double blind randomized control trial (RCT) with a larger set of patients will be worthwhile in the localization of this treatment aimed at improving the symptoms of ASDs.

Exploratory: to determine efficacy of high dose D3 replacement for improvement in the core symptoms of autism, including sociability, eye contact, anger outbursts, stimming behavior, and sleep, as determined by parental and clinical evaluation scales.

data is still being collected

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Autism from DSM-IV TR and ADOS
* Moderate but less than severe on CGI-Severity scale
* IQ \> 40
* ZRT 25(OH)D blood spot test \< 30 ng/ml
* Age 3-8 years old

Exclusion Criteria:

* Developmental delays prior to 12 months of age
* history of head trauma
* seizure in the past year
* bleeding disorder
* history of kidney or liver disease
* clinically significant low white blood cell count
* PDD-NOS, Rett's syndrome, Childhood Disintegrative Disorder or Fragile X syndrome
* current supplementation with Vitamin D, Vitamin A or cod-liver oil
PK/PD, Safety and Tolerability of PHP-201 Topical Eye Drop in Korean and Japanese Healthy Subjects

An open label, multiple-dose, phase 1 clinical trial to evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of PHP-201 topical eye drop in Korean and Japanese healthy subjects

Primary: The evaluation of pharmacokinetic properties of repeating PHP-201 topical eye drop Secondary: The evaluation of pharmacodynamic, safety and tolerability of repeating PHP-201 topical eye drop

Eligibility Criteria:
Inclusion Criteria:

1. Fully informed about the purpose of the study
2. BMI of 18.0 kg/m² or more and 27.0 kg/m² or less who are between 19 and 50 years of age
3. No congenital or chronic disease and no medically symptomatic findings

Exclusion Criteria:

1. Clinically significant disease history or disease history that may affect the absorption, distribution, metabolism and excretion of the drug, or ophthalmic corneal surgery
2. had BCVA worse than logMAR 0.2(20/30snellen) or IOP \< 10mmHg or \>21mmHg in either eye
3. Abnormalities of clinical examination (SBP, DBP, pulse rate, AST, ALT, Total bilirubin, eGFR and Serum test, ECG)
4. Allergy, drug hypersensitivity and substance abuse
5. Forbidden drug and diet
6. Blood donation and transfusion
Investigation of Chronic Inflammatory Processes in Male Individuals With Hypohidrotic Ectodermal Dysplasia

X-linked hypohidrotic ectodermal dysplasia (XLHED) is a complex genetic disorder characterized by lack of sweat, sebaceous, submucous, Meibomian and mammary glands, sparse hair and eyebrows, and oligodontia. Insufficient function of the respective glands may lead to chronic inflammatory processes in airways and eyes of the affected individuals. The investigators will quantify sweat glands of XLHED patients, assess chronic conjunctivitis and blepharitis in conjunction with quantitative and/or qualitative alterations of lacrimal fluid in these subjects, evaluate lung function and assess chronic inflammatory processes in the airways by NO measurements. The data should provide a basis for genotype-phenotype correlations.


Eligibility Criteria:
Inclusion Criteria:

* for patients: X-linked hypohidrotic ectodermal dysplasia caused by mutations in the gene EDA
* written informed consent

Exclusion Criteria:

* acute respiratory disease
* acute allergic problem, e.g. allergic coryza
* implantable electronic devices, e.g. pacemaker
AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies

This study is a planned research project to test and demonstrate the feasibility of using the Femom device for monitoring fetal heart rate remotely.

The main goal is to learn if the remote recordings using Femom provide reliable information about the baby's heart rate. We will also establish reference standards of heart rate variability in uncomplicated pregnancies at different stages of pregnancy. Additionally, we will compare the heart rate variability in FGR and diabetic pregnancies to normal pregnancies.

The Femom device is a non-invasive fetal ECG (NIFECG) device which has been developed for self application and remote monitoring. Women from three different cohort groups (controls, FGR and insulin dependent diabetes) will be approached and asked to monitor their baby at home once a day. Women in the control group will be asked to do this once a day for one week, the FGR pregnancies until delivery and the insulin dependent diabetics just from 36 weeks until delivery.

The data will be collected and analysed retrospectively to assess compliance of the participants with the study protocol, signal quality and establish reference standards in relation to gestation within the control group. Heart rate variability measures in the FGR and diabetes arm will be compared to the reference standards in the control group. Outcomes of the pregnancy.

Feedback regarding the usability of the device will also be collected using a feedback questionnaire to assess the feasibility of home antenatal monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Singleton live pregnancy
* \> 26 weeks gestational age
* Able to speak English or available NHS interpreter

Exclusion Criteria:

* Women below 18 years of age
* Women with an intellectual or mental impairment
* Women with a known allergy or hypersensitivity to ECG gel electrodes
* Known fetal cardiac or genetic abnormality.
* Patient with existing dependent or unequal relationships with any member of the research team, the researchers(s) and/or the person undertaking the recruitment/consent process.
* Inability to access interpreter.
Myeloid Suppressors in Inflammation

Myeloid-derived suppressor cells (MDSC) have been studied for their ability to suppress T cell responses in vivo and in vitro. As a result, MDSC can regulate cellular responses to chronic inflammatory conditions such as cancer, leading to the induction of tolerance and, ultimately, tumor escape from immune surveillance.


Eligibility Criteria:
Inclusion

1. Ages eligible for study: 18 to 60 years
2. Genders eligible for study: male and female
3. Signed and dated written informed consent is obtained prior to study blood draw.
4. Subjects being actively treated for chronic moderate to severe asthma based on National Heart Lung and Blood Institute guidelines (figure 1). Subjects must carry the diagnosis of asthma (made by a physician) for a minimum of six months.
5. Subjects within the first seven days of an acute asthma exacerbation, as determined by the referring physician.
6. Able to give informed consent.

Exclusion Criteria:

1. Use of systemic corticosteroids within the previous two weeks.
2. Pregnant and/or lactating females.
3. Current tobacco use.
4. Severe psychiatric illness.
5. Current illicit substance abuse or dependence and/or abuse of alcohol.
6. Current use of anti-microbial medications.
7. Primary or secondary immunodeficiency.
8. Any clinically significant uncontrolled medical condition that would put the patient's safety at risk.