cyrilzakka/clinical-trials huggingface dataset:
Optimizing Diagnostics Of Arrhythmia Events In Children Using Intelligent Telemetric Solutions

The purpose of this study is to assess efficacy of prolonged Full Disclosure electrocardiogram (ECG) monitoring and signal analysis using advanced telemetric technology to diagnose arrhythmia in comparison with standard diagnostic procedure.

Irregular and/or rapid beating of the heart called heart palpitations can occur in individuals without heart disease and the reasons for their palpitations are unknown. Together with heart palpitations silent arrhythmia may be present that could lead to serious complications (eg. stroke). In others, palpitations result from heart rhythm disturbances, sometimes life threatening. Standard diagnostic methods such as 24 hours Holter electrocardiogram (ECG) monitoring or Event Holter do not guarantee early diagnosis of the arrhythmia. Prolonged heart rhythm recording and analysis using an automatic full disclosure telemetric device can increase probability of arrhythmia diagnosis and early administration of applicable treatment. Study patients will be diagnosed using standard Holter ECG monitoring, Event Holter or 30 days telemetric ECG monitoring. Efficacy of telemetric monitoring in diagnosis of cardiac arrhythmia will be assessed in comparison with the standard Holter monitoring and Event Holter

Eligibility Criteria:
Inclusion Criteria:

* History of symptoms that can be potentially caused by cardiac arrhythmia occuring at least 4 times a year
* Ability to operate the telemetric device at home
* Informed consent undersigned by the parents
* Informed consent undersigned by the child if over 16 years of age

Exclusion Criteria:

* Previously recorded tachycardia evidence
* Wolff Parkinson White syndrome
* Inability to operate the telemetric device at home
* Inability to comply with the study protocol
Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis

The purpose of this study is to the effect of squeezable bottle nasal irrigation device with syringe in children with sinusitis in symptom score and satisfaction to nasal irrigation

sinusitis is the one of common diseases in Thailand. Nasal irrigation has been used as an adjunctive treatment.In previous study shown that buffer hypertonic nasal irrigation have more effective to decrease symptom in patient sinonasal disease when compare to normal saline.Until now, there are no clear data comparing the effectiveness on sinonasal symptom of the various devices use in children with sinusitis. The purpose of this study was to compare the effect of squeezable bottle nasal irrigation device with syringe in children with sinusitis in symptom score and satisfaction to nasal irrigation.

Eligibility Criteria:
Inclusion Criteria:

1. age 3-15 years
2. diagnose sinusitis by each of following criteria 2.1 persistent upper respiratory infection symptoms \> or = 10 days 2.2. severe upper respiratory infection symptom with greenish discharge per nose or periorbital swelling 2.3 double sickening of upper respiratory infection symptoms

Exclusion Criteria:

1. patient who has history of penicillin allergy
2. patient who has complication of sinusitis
3. patient with a history of nasal anatomical defects
4. patient who has immune deficiency or primary ciliary dyskinesia
Effects of Propofol on Respiratory Adverse Events During Extubation in Children Undergoing Tonsil Adenoidectomy

The main objective of this study was to investigate whether propofol assisted extubation could reduce the incidence of respiratory adverse events in children with tonsil adenoidectomy.

In pediatric surgery, the incidence of perioperative respiratory adverse events in children undergoing tonsillectomy is higher than that of general surgery. Studies have shown that intravenous induction can reduce perioperative respiratory adverse events compared with inhalation induction. There are also literatures that show that intravenous anesthesia can significantly reduce cough and hemodynamic reactions during the wake period compared with balanced anesthesia.However, inhalation anesthesia is easier to use and can monitor the depth of anesthesia, so it is used more frequently than intravenous anesthesia.The incidence of respiratory adverse events has not been compared between intraoperative sevoflurane maintenance and extubation with a small amount of propofol versus total sevoflurane maintenance and extubation.The objective of this study was to investigate whether propofol can reduce perioperative adverse respiratory events in children undergoing tonsillectomy.

Eligibility Criteria:
Inclusion Criteria:

* age: 3\~8 years old,
* general anesthesia for tracheal intubation in ASA Grade I to III patients undergoing tonsil adenoidectomy,
* the operation time is 10\~60 minutes,
* sign informed consent.

Exclusion Criteria:

* patients with congenital heart disease, tumor, severe lung disease, liver and kidney function disease, nervous system disease, coagulation dysfunction, etc,
* children who do not consent to the test.
EFFICACY OF AN EXERCISE PROPRIOCEPTIVE PROGRAM IN INSTITUTIONALIZED ELDERLY

Knowing the effects of proprioceptive exercise program in improving balance, gait and risk of falls in institutionalized elderly.

The aim of this study will be to determine the effects of proprioceptive exercise program in improving balance and gait as well as reducing the risk of falls in institutionalized elderly in a healthcare center. To evaluate this effect, a total of 45 subjects will participate in a longitudinal and controlled trial. Inclusion criteria will be over 65 years olds, be institutionalized in the center and have ability to read and write.

Thereafter, participants will be separated into two different groups (experimental and control). Randomization was performed using sealed envelopes with different numbers of intervention inside. Both groups will be evaluated both at the start of the first session and in the last working session.

The control group performed a geriatric revitalization program as the experimental group. Besides this one, experimental group performed a program of proprioceptive exercises. The intervention rate will 2 weekly sessions for 12 weeks for both groups (24 sessions), lasting 55 minutes. The variables analyzed were: the questionnaire risk of falls in hospital (MORSE), Tinetti scale, the test Timed Up and Go (TUG), the time of one leg and the Cooper test running 12 minutes.

The data analysis will perform using the Statistical Package for the Social Sciences (SPSS statistical software), version 19.0 for Windows, Chicago.

To determine the normal distribution of the data the Shapiro-Wilks test and comparison by ANOVA was performed. The values obtained in the pretest and posttest assessment for each variable will be compared by Student t test for related samples or by the Wilcoxon rank test.

Eligibility Criteria:
Inclusion Criteria:

* Being institutionalized,
* own ability to read and write,
* and access the study voluntarily.

Exclusion Criteria:

* Significant degree of cognitive impairment;
* intolerance moderate physical activity, caused by cardiovascular or respiratory disease,
* as well as those who did not complete 90% of the sessions.
Spirulina Platensis Supplementation and Calorie Restriction in Obese Men : A Randomized Controlled Trial Protocol Study

The goal of this clinical trial is to evaluate the effects of spirulina platensis supplementation and calorie restriction on anthropometric parameters, body composition, lipid profile, insulin resistance, serum superoxide dismutase (SOD) levels, and serum malondialdehyde (MDA) levels in men with obesity. The main question it aims to answer are:

What is the effect of spirulina platensis supplementation and calorie restriction on anthropometric parameters, body composition, lipid profile, insulin resistance, serum Superoxide Dismutase levels, and serum Malondialdehyde levels in obese individuals?

Participants will be respondents were given spirulina supplements for 30 days with a dose of 2x2 capsules 450mg

Researchers will compare intervention group with placebo group that weren't given spirulina supplementation to see if there is any effects on anthropometric parameters, body composition, lipid profile, insulin resistance, serum Superoxide Dismutase levels, and serum Malondialdehyde levels

Spirulina supplement intervention on subjects with male gender aged 25-55 years, which will be intervened for 4 weeks / 30 days, before the intervention will be taken anthropometric parameters, body composition, lipid profile, insulin resistance, serum Superoxide Dismutase levels, and serum Malondialdehyde levels.

After that, spirulina supplement intervention will be given at a dose of 2x2 / day, and follow-up will be carried out every week, after 30 hours of intervention,spirulina supplement distribution is carried out by research assistants every 2 days.

Will be taken again to conduct anthropometric parameters, body composition, lipid profile, insulin resistance, serum Superoxide Dismutase levels, and serum Malondialdehyde levels.

The aim is to find out if there is an effect of spirulina supplementation on anthropometric parameters, body composition, lipid profile, insulin resistance, serum Superoxide Dismutase levels, and serum Malondialdehyde levels.

Eligibility Criteria:
Inclusion Criteria:

* Male Age 25 - 55 years
* BMI ≥ 30 kg/m2
* Waist Circumference \> 90 cm
* Low physical activity (Sedentary life style)
* If taking weight loss supplements are willing to stop the dietary supplements, food or drinks.
* Not undergoing a diet program.

Exclusion Criteria:

* History of kidney disease, atherosclerosis, cancer, and acute infections.
* Post-surgery in the last 3 months.
* Deficit in daily calorie requirement.
* Smoking habit and alcohol dependence.
* Use of hormonal drugs, antidepressant drugs, antibiotics, antidiuretic, glucocorticoids and use of vitamin or mineral supplements in the last three months.
* Refusal to sign the informed consent and in the study if not completing all stages will be excluded.
Comparison of the Effects of Transcutaneous Electrical Nerve Stimulation Protocols in Women With Overactive Bladder

The aim of our study is a comparison of the effects of transcutaneous electrical nerve stimulation (TENS) protocols in women with overactive bladder (OAB).

OAB is a condition defined by the International Continence Society as the presence of urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. TENS has positive effects on OAB. However, there are not enough studies on how often this stimulation is applied. Studies are needed on this subject.

Eligibility Criteria:
Inclusion Criteria:

* Being in the age range of 18-65 ,
* Having diagnosed with OAB,
* Being a volunteer

Exclusion Criteria:

* Being pregnant,
* presence of severe pelvic organ prolapse,
* malignant disease,
* urinary infection,
* neurological disease,
* have electronic and metal implant,
* loss of sensation,
* lumbosacral peripheral nerve lesion
Observational Study of the Durability of Seroconversion Chronic HBV Patients Who Seroconverted in a Previous Gilead-Sponsored Study of ADV.

To investigate the durability of HBeAg seroconversion in patients with chronic hepatitis B virus infection (HBV) who have seroconverted while participating in a previous Gilead-sponsored study of adefovir dipivoxil.

The primary objective of this study is to investigate the durability of HBeAg seroconversion in patients with chronic hepatitis B virus infection (HBV) who have seroconverted while participating in a previous Gilead-sponsored study of adefovir dipivoxil.

The secondary objective of this study is to investigate the durability of HBeAg loss in patients with chronic hepatitis B virus infection (HBV) who have experienced durable HBeAg loss while participating in a previous Gilead-sponsored study of adefovir dipivoxil.

Eligibility Criteria:
Inclusion Criteria:

* Must have met all inclusion criteria and none of the exclusion criteria and must have demonstrated HBeAg seroconversion or durable HBeAg loss as defined by the protocol in one of the following Gilead-sponsored studies: GS-96-412, GS-98-437, GS-00-461 or ongoing or future Gilead-sponsored studies identified by the Sponsor to be eligible for this study. Other patients who were enrolled in a now closed Gilead-sponsored study of ADV (GS-94-404, GS-96-412 Initial Phase or GS-96-413) and had previously demonstrated seroconversion or durable HBeAg loss during their participation will be evaluated by the clinical research organization (CRO) medical monitor for participation in this study on a case by case basis.
* Have documented negative serum HBeAg with or without positive anti-HBe present at the two study visits prior to the final visit of the previous study.
* A patient who has documented negative serum HBeAg without positive anti-HBe must also have undetectable serum HBV DNA (less than 1000 copies/mL using Roche Amplicor PCR Assay) and normalized ALT (less than ULN) confirmed during these two studies.
* All patients must be able to give written informed consent and comply with requirements of this study.

Exclusion Criteria:

* Patients who seroconvert or experience durable HBeAg loss during their participation in study GS-00-480 will not be eligible.
* Any serious or active medical or psychiatric illness that, in the opinion of the investigator would interfere with patient treatment, assessment or compliance with the protocol.
* Receiving any of the excluded medications listed in the protocol.
* Inability to comply with study requirements.
PPI to Promote the Psychological Well-being of Children Living in Poverty

Positive psychology interventions use positive psychology techniques to identify meaning and value in life events to raise positive feelings and emotions. Application of PPIs has steadily increased in clinical and non-clinical samples. However, that meta-analysis did not include any study in a Chinese population, and it remains unclear whether PPIs are applicable in the Hong Kong Chinese context.

A randomized controlled trial will be conducted. A convenience sample of 120 patients age 13 to 17 years with no cognitive and/or behavioral problem(s) will be recruited in secondary school around Kwai Chung Estate Participants will be randomized into experimental and control group. The experimental group, who will receive a 1.5-hour workshop covering positive psychology techniques delivered by a qualified research assistant, in groups of less than 5 people, and a booster intervention at 1 week. The control group will received no intervention. Data collection will be conducted at baseline, 1 week, 1month, 3months and 6 months for both groups.

Eligibility Criteria:
Inclusion Criteria:

* Age from 13-17
* Can read Chinese and speak Cantonese

Exclusion Criteria:

* with identified cognitive and/or behavioral problem(s)
* with identified mental problem(s)
* participating in any mental health service/programme and/or receiving any psychiatric medication.
Role of US,Doppler in Major Salivary Gland Diseases

To evaluate the role of gray scale and Doppler ultrasound in characterizing of parotid and submandibular gland lesions in comparison to biopsy if needed

\* Salivary glands are affected by variety of disease processes which include infective, inflammatory, systemic, obstructive and neoplastic conditions . Clinical examination alone will not provide the correct diagnosis of salivary gland pathologies. Thus, radiological evaluation is essential in correct diagnosis .

USG plays a significant and crucial role in the diagnosis and management of salivary gland lesions. Results of the USG examination alone may suggest the final diagnosis or provide important differential diagnostic data . USG can differentiate intraglandular from extraglandular lesions in 98% of cases. It can differentiate salivary gland lesions as focal or diffuse. Characterisation of focal lesions into benign and malignant can be done by evaluation of edges. With high resolution transducers USG is better than CT or MRI in detection of unsharp borders .

Color Doppler findings are helpful in characterising the pathologies. It is helpful in diagnosing pleomorphic adenoma. Doppler findings of intralesional vascularity, type and grade of vascularity, PSV, RI and PI are useful in differentiating benign from malignant tumours . Pathological diagnosis can be established by Fine Needle Aspiration Cytology (FNAC). FNAC is preferably done under USG guidance. This helps in further enhancing ability of USG to differentiate between benign and malignant lesions .

Other radiological investigations for evaluation of salivary gland pathologies are plain radiography, sialography, CT, MRI and PET-CT .

Sometimes it is not possible to visualize lesions completely on USG because of their location, extension into the deep lobe of the parotid gland or behind the acoustic shadow of the mandible In these situations, further imaging with CT or MRI is necessary.

Eligibility Criteria:
Inclusion Criteria:

- Patients in different age and sex groups with neck swelling, pain or any complaint related to major salivary gland detected by clinical examination.

Exclusion Criteria:

* patients who refused to sign a consent
Cemented Acetabular Cups Clinical Study

This clinical study has the aim to evaluate clinical, radiographic, patient-reported outcomes of total hip arthroplasty with the implant of Mueller cemented acetabular cups up to 2 years after surgery, in order to assess the performance of the device. Furthermore, it aims to collect short-term survivorship of the implant and the incidence of early complications.


Eligibility Criteria:
Inclusion Criteria:

1. The patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee;
2. The patient diagnosis is one or more of the following:

   * Patient with advanced articular destruction generated by primary degenerative or post-traumatic arthrosis or rheumatoid arthritis;
   * Patient with avascular necrosis of the femoral head or fracture of the femoral neck;
   * Patient with congenital or acquired deformity;
   * Patient with failures of previous operations, like osteosynthesis, articular reconstruction, arthrodesis, hemi-arthroplasty or total arthroplasty.
3. The patient is willing and able to complete scheduled follow-up evaluations as described in the Patient Information Sheet;

Exclusion Criteria:

The patient should be excluded from the study if he/she meets any of the following criteria, which reflect the cemented acetabular cup contraindication for use:

1. Acute or chronic infections, local or systemic infections;
2. Serious muscular, neurological or vascular diseases affecting the concerned limb;
3. Any concomitant disease and dependence that might affect the implanted prosthesis;
4. Allergy to material;
5. Metal-on-metal systems: patients with renal impairment.
6. Patient's age\<18
7. Female patients who are pregnant, nursing, or planning a pregnancy.
VALEO: A Post Authorization Study, Designed to Learn More About the Safety and Effectiveness of the Use of Bortezomib in the Netherlands

The main purpose of this study is to evaluate safety and effectiveness of the treatment of multiple myeloma with bortezomib in daily practice in the Netherlands.

Bortezomib has become commercially available in the European Union in May 2004 for the third line treatment of patients with multiple myeloma. The registration was based on two phase II studies while more research was ongoing. Some experience was already gained with the use of this product in the Netherlands by means of a compassionate use program before the initial registration. However, the data available from the use of bortezomib in daily clinical practice is limited. Therefore, there is a need to closely study the use of bortezomib in daily clinical practice. During the course of the study, the registration of bortezomib was extended. In April 2005, bortezomib was registered for second line treatment of multiple myeloma. Consequently, safety and effectiveness data from patients in this line of treatment could be collected in this project as well (arm A). Data of a large phase 3 trial showed that response rates differ between patients treated for multiple myeloma in the second line and patients treated in the third line. Therefore the protocol was amended to compare the response rates in two arms, dependent on the number of previous treatment lines for multiple myeloma: The protocol was also amended to determine the time to progression and response rate in both patients who received thalidomide earlier versus patients who didn't (arm B). ARM A: Patients with relapsed multiple myeloma who have received not more than 1 previous line of treatment and show progression on that therapy; ARM B: Patients with relapsed or refractory multiple myeloma who have received at least 2 prior lines of treatment and show progression on most recent therapy. This project is a 'post authorization study (PAS)'. This means that only routinely available medical data is collected, with the patients' permission, and no additional interventions or diagnostic procedures should be done specifically for this study. Because the study is observational, dosage, administration and duration of treatment is at discretion of treating physician.

Eligibility Criteria:
Inclusion Criteria:

* Patients have to sign a statement that they agree with collection of their clinical data for this project
* the patient is eligible, in the investigator's opinion, based on the criteria in the summary of product characteristics for bortezomib

Exclusion Criteria:

* If patients meet the eligibility criteria, there are no exclusion criteria.
Postoperative Pain in the Surgical Treatment of Hemorrhoids: Conventional Hemorrhoidectomy With a Monopolar Electric Scaler VS Bipolar Energy With Caiman® (Aesculap®)

To demonstrate that postoperative pain secondary to Milligan and Morgan hemorrhoidectomy with Caiman® (AESCULAP®) and subsequent oral conventional analgesia is at least not greater than that generated after hemorrhoidectomy with monopolar diathermy and intravenous analgesia with care home at discharge.

In the treatment of coloproctological pathology, one of the most important problems is postoperative pain. Especially in the management of hemorrhoids treatment. There are different approaches but in all of them pain is the predominant symptom.

There are some less painful techniques but the gold standard continues to be hemmorrhoidectomy, which is associated with postoperative pain. Some actions have been taken to control pain to avoid the admission of patients, but there are still problems in this regard.

Our group aims to study the effect of energy change for performing hemorrhoidectomy on postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* All patients with 2 or 3 bundles of grade III-IV hemorrhoids (Goligher classification) clinically symptomatic and subject to outpatient hemorrhoidectomy
* Voluntary participation.
* ASA I-II-III.

Exclusion Criteria:

* Failure to meet the inclusion criteria.
* ASA IV.
* Allergic to Paracetamol, derivatives of morphine.
* Allergic to NSAIDs.
* Synchronous colorectal neoplasia.
* Coagulation disorders.
* Thrombosed hemorrhoid.
* Inflammatory bowel disease.
* Liver cirrhosis and/or portal hypertension.
* Pregnant women.
* Difficulty following up by phone and/or in person.