cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Two Doses of Intranasal Dexmedetomidine for Premedication in Children

The purpose of the study is to determine if 4mcg/kg of intranasal dexmedetomidine is better than 2mcg/kg in successfully sedating a child prior to induction of anesthesia.

Dexmedetomidine is a selective alpha-2 adrenoreceptor agonist that has sedative, anxiolytic and analgesic properties without causing respiratory depression. It has been administered safely and effectively via a number of routes including as an intravenous infusion, intramuscularly, intranasally, buccally and orally .

Yuen et al established that the median time of onset of sedation is 25-30 minutes, making it an ideal agent for preoperative sedation. The same group also studied doses of 1 mcg/kg and 2 mcg/kg as a sedative premedication and found that the success rates of appropriate sedation at induction in children aged 1 to 8 years were 53% and 66% respectively, with a dose related increase in successful sedation.

Much higher doses of dexmedetomidine have also been used safely. Administered intravenously, 3mcg/kg of dexmedetomidine has been shown to provide satisfactory sedation for paediatric MRI in 97% of cases, without adverse effects.

The investigators aim to show that high dose intranasal dexmedetomidine is a safe, effective and an easily administered sedative premedication.

The investigators hypothesise that 4mcg/kg compared to 2mcg/kg of intranasal dexmedetomidine will lead to at least a 20% increase in the proportion of satisfactorily sedated patients at the time of anaesthesia induction.

The primary outcome will be the proportion of children with satisfactory sedation at the time of anaesthesia induction.

Suitable patients will be identified from the theatre lists and consent will be sought from their legal guardians during preassessment clinic or during their anaesthetic preoperative assessment on the ward.

In a previous study, 66% of children aged 1-5 years were satisfactorily sedated at the time of induction with 2 mcg/kg of intranasal dexmedetomidine. In order to find a 20% difference with 4 mcg/kg of dexmedetomidine, the investigators' sample size needs to be 140 (70 in each group), for a power of 0.8 and a 5% false positive rate.

The demographic data will be analysed by t test and chi-square test. The proportions of satisfactory sedation will be analysed by chi-square test. The onset sedation time and duration of sedation will be analysed by survival analysis. The vital signs over times will be expressed by percentage changes from baseline and estimated by mean and standard errors. A p-value\<0.05 will be considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* All children of American Society of Anesthesiologists (ASA) physical status classification I or II (healthy) between the ages of 6 months and 5 years undergoing surgery at Queen Mary Hospital

Exclusion Criteria:

* Any patient receiving other sedative premedication, allergy to dexmedetomidine, organ dysfunction, cardiac arrhythmia and congenital heart disease.
The Correlation Between the Thickness of Lipid Layer and the Meibomian Gland Dysfunction

The purpose of this study is to assess the correlation between the thickness of lipid layer and the meibomian gland dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent the Meibomian Gland Dysfunction through the signs.

Exclusion Criteria:

* Eye surgery history
YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) in Elementary Schools

The aim of this study is a first evaluation of the effectiveness of the YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) to evaluate potential effects in stress reduction and concomitant psychological parameters.


Eligibility Criteria:
Inclusion criteria:

* Students from participating primary schools in Berlin aged 6-12 years
* Written declaration of consent of the parent or legal guardian

Exclusion criteria:

* Serious chronic or acute diseases
* Immobility or serious restriction for gymnastic exercises due to orthopaedic, neurological or other medical causes
* Participation in another study
Diagnostic Value of Modified Cough Reflex Test With Staged Water Swallow Test in Post-Stroke Patients Showing Dysphagia

The investigators conducted staged water swallow test (sWST) and modified cough reflex test (mCRT) on stroke patients referred for videofluoroscopic swallowing studies (VFSS) due to dysphagia. The patients were followed for up to four weeks to examine the incidence and timing of aspiration pneumonia, the relationship between these tests and VFSS results, and the diagnostic value of these tests as screening tools. Descriptive statistics will be presented for the incidence and timing of pneumonia, as well as the results of the SWST and MCRT. Regression analysis will be conducted to determine the explanatory power of each aspiration indicator (sWST and mCRT) in predicting aspiration or aspiration pneumonia. Additionally, using the VFSS results and the diagnosis of aspiration pneumonia as gold standards, the validity, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), odds ratio (OR), and relative risk (RR) for sWST, mCRT, and their combination will be calculated to evaluate their diagnostic value.


Eligibility Criteria:
Inclusion Criteria:

* either ischemic or hemorrhagic stroke confirmed by a computed topography or magnetic resonance imaging
* aged 20 years or older
* signs or symptoms of dysphagia.

Exclusion Criteria:

* inability to maintain sitting posture with support
* dyspnea requiring oxygen supplementation
* diagnosed with aspiration pneumonia at enrollment
* diagnosed with co-existing major neuromuscular disorders affecting swallowing
* diagnosed with infectious diseases requiring isolation
* refusal to participate
Opioid Titration With 12.5 ug/h Fentanyl Transdermal Patch vs Orally Morphine for Opioid-naïve Patients With Moderate Cancer Pain

Opioid is recommended for moderate cancer pain in WHO 3-step analgesic ladder. Transdermal administration of the strong opioid fentanyl was originally developed for patients unable to swallow analgesics because of malignancies in the head and neck region or the gastrointestinal tract, painful lesions in the mouth, or periods of nausea, vomiting, or bowel obstruction. The EMA recognizes that in exceptional clinical circumstances, the 12 μg/h fentanyl patch could be considered. To our knowledge, there is not a phase III trial to explore the efficacy and safety of 12 μg/h fentanyl patch in opioid-naive patients with moderate cancer pain.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years old or more;
2. ECOG PS ≤3 ;
3. Opioid tolerance not moderate pain patients (4≤ NRS ≤6 on 11 points, 0 no pain, 10 most pain);
4. No taking strong opioids for the last 30 days;
5. Estimated life expectancy of at least 3 months;
6. Ability to communicate effectively with the study personnel about the nature of their pain;
7. Ability to complete a diary;
8. Cancer pain is expected to be relatively stable and last for more than 48 hours;
9. The patient understands the research process, agrees to participate in the trial, cooperates with the treatment and visit plan, and signs an informed consent form.

Exclusion Criteria:

1. Known allergy to any ingredient in both fentanyl and morphine;
2. No cancer associated pain or the pain of unknown cause, such as osteoarthritis pain, acute abdominal pain;
3. Primary tumors or metastases in the brain;
4. An active skin disease that precluded application of the transdermal system;
5. Anti-cancer therapy (radiotherapy, chemotherapy, targeted therapy, etc.) is used during the study period, and the treatment has an impact on the analgesic effect or adverse reactions of analgesic drugs;
6. No bowel movement within 3 days before the screening period;
7. The patient has contraindications to the use of opioids: such as respiratory depression; head damage; paralytic intestinal obstruction; acute abdomen; chronic obstructive airway disease; pulmonary heart disease; chronic bronchial asthma; hypercapnia;
8. Used monoamine oxidase inhibitor within 1 week before randomization;
9. Any abnormal laboratory test results with obvious clinical significance, such as creatinine value ≥ 2 times the high limit of the normal value or ALT or AST ≥ 2.5 times the high limit of the normal value (for patients with liver metastases can be relaxed to ≥ 5 times the high limit of the normal value) ;
10. Patients with a history of drug abuse;
11. Patients with mental illness or cognitive impairment;
12. Pregnant or lactating women; subjects who have a pregnancy plan within 1 month after the test (including male subjects);
13. Participate in the drug trial (including the trial drug) within 3 months before the trial.
Caminemos! Trial to Increase Walking Among Sedentary Older Latinos

The purpose of this study is to examine the efficacy of a multifaceted behavioral intervention aimed at raising walking levels among sedentary older Latinos.

Regular physical activity contributes to the health and quality of life of older adults, but unfortunately only 20% of men and 25% of women aged 65 years and greater meet the minimal national guidelines for physical activity. Older Latinos have higher rates of diseases that are most likely to benefit from physical activity, but have disproportionately high rates of sedentary lifestyle. To address this major public health problem, this study will implement and evaluate a multifaceted intervention to raise and sustain walking levels among older Latinos.

A total of 600 sedentary older Latinos will be recruited from community-based senior centers in the greater Los Angeles region. The specific aims of the study are to test the effect of the intervention on:

1. the change in steps per week measured by digital pedometer from baseline to 1, 12, and 24-month follow-up;
2. self-reported physical activity level and intervening constructs (including expectations regarding aging and self-efficacy expectations for physical activity);
3. psychosocial health constructs, physical performance measures, and clinical health outcomes.

The core of the intervention consists of a series of 4 weekly 1-hour group discussion sessions that utilize attribution retraining techniques from the field of motivational psychology in combination with behavioral strategies based in social cognitive theory. Discussion sessions will be conducted at senior centers and led by a bilingual health educator; each session will be followed by a 1-hour exercise class aimed at increasing strength, flexibility and endurance. During the discussion sessions, the health educator will administer a structured culturally-tailored curriculum in which participants are taught to raise their expectations for physical activity with aging and not to attribute being sedentary to "old age." The 4 weekly sessions will be followed by monthly sessions for 11 months, and sessions every 2 months for the following 12 months (total intervention duration = 24 months). Participants will be randomized to 1 of 2 arms:

1. intervention arm: receiving the discussion session and the exercise class;
2. control arm: receiving just the exercise class with the same frequency and duration as the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* Aged 60 years or older
* Self-identifying as Latino/Hispanic
* Not currently participating in 20 minutes or more of physical activity 3 times a week
* Willingness to take brief physical activity screening test and if do not pass, provide the name of a physician who has seen the patient in the recent past

Exclusion Criteria:

* Plans to move from the area in the next 24 months
* Unable to participate in 1-hour group discussion
* Unable to walk
* Physician stating that patient is not medically able to participate
* Family member already participating
* Substantial cognitive impairment (determined by a screening test)
Video-Assisted Surgery in Treating Patients With Non-small Cell Lung Cancer

RATIONALE: Video-assisted surgery may be an effective treatment and have fewer side effects than conventional surgery in patients with non-small cell lung cancer.

PURPOSE: Phase II trial to study the effectiveness of video-assisted surgery in treating patients who have non-small cell lung cancer.

OBJECTIVES: I. Determine the feasibility of performing video-assisted thoracic surgery (VATS) lobectomy, without significant morbidity or perioperative mortality, in patients with small (no greater than 3.0 cm), peripheral, non-small cell lung cancer. II. Determine the rate at which a thoracotomy must be carried out to complete a VATS lobectomy in these patients. III. Describe the complications associated with this procedure. IV. Describe the length of the operative procedure, duration of chest tube stay, and length of hospitalization in this patient population. V. Describe the survival and failure-free survival, over a 5-year period, in this patient population following this procedure.

OUTLINE: Patients undergo video-assisted thoracic surgery (VATS) lobectomy, which requires 3 small incisions on the side of the chest. The entire anatomic pulmonary lobe is removed, as well as all peribronchial lymph nodes and anterior hilar lymph nodes. If it is not possible to remove the lobe using the VATS approach, then 1 of the incisions is converted to a standard thoracotomy. Patients are followed every 4 months for the first 2 years, and then every 6 months for the next 3 years.

PROJECTED ACCRUAL: A total of 135 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Suspected or histologically documented non-small cell lung cancer Solitary, peripheral lung lesion that is no greater than 3.0 cm No metastatic disease No positive lymph nodes at mediastinoscopy At least 5 years since diagnosis of non-small cell or small cell lung cancer

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: FEV1 at least 1.0 L or at least 50% of predicted Other: No significant comorbid medical or psychiatric condition No other active malignancy other than nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Not specified
Automated Screening for Clinically Ascertained Loss of Cerebral Functions

Rationale: The low organ donation rate in Germany is associated with the inadequate identification of patients at risk of developing irreversible loss of brain function (ILBF; i.e. brain death). An automated digital screening tool, DETECT (AutomateD ScrEening for Clinically AscerTainEd Loss of Cerebral FuncTions in Patients with Severe Brain Damage), has been developed to prospectively identify intensive care patients who are at risk of developing ILBF.

Objective: The objective of the study is to evaluate the effectiveness of an automated digital screening tool in the identification of patients with severe brain damage who are at risk of impending ILBF compared to standard practice without digital support.

Study design: Stepped-Wedge, multicenter, cluster-randomized, controlled trial

Study population: The study includes patients aged 18 years or older with primary and/or secondary acute brain damage, requiring mechanical ventilation, and who are deceased upon hospital discharge.

Intervention: DETECT periodically processes real-time data from the corresponding electronic medical record system to screen for a combination of coma, indicated by a Richmond Agitation Sedation Scale (RASS) score of - 4 or - 5 or Glasgow Coma Scale (GCS) score of 6-3, along with manually assessed absence of bilateral pupillary light reflexes. Both findings are considered early indicators of impending ILBF. In case of positive screening results, an automated notification will be sent via the hospital's email server to the corresponding transplant coordinators and intensivists. The email sent aims to prompt clinical assessment of the reported patient and, if necessary, initiate a guideline-based ILBF examination.

Primary study endpoint: The primary endpoint is the identification of patients who eventually develop ILBF during hospitalization.

Secondary study endpoints: Secondary outcomes encompass the missed identification of potential ILBF cases (as retrospectively classified) and the rate of deceased organ donations. Upon completion of the study, a survey will be conducted to investigate the stakeholders' experiences with DETECT.


Eligibility Criteria:
Inclusion Criteria:

* Primary and/or secondary acute brain damage
* At least 18 years or older
* Necessity of mechanical ventilation
* Deceased upon hospital discharge

Exclusion Criteria:

• none
Effects of Breaking Sitting on Human Behaviour and Metabolic Health

This study primarily aimed to investigate effects of breaking up prolonged sitting with intermittent brisk walking in healthy young individuals on (1) post-trial human behaviours including energy intake and physical activity under free-living conditions and (2) cognitive performance in a simulated workplace environment.


Eligibility Criteria:
Inclusion Criteria:

* Without current and any history of brain injury, neurological disorder, cardiometabolic related diseases, diabetes or cancers.
* Weight stable (not self-reported weight change ± 3 kg at least 3 months)
* Body mass index (BMI) ranging between 18.5 to 27 kg/m2
* Can walk safely on a treadmill

Exclusion Criteria:

* Smokers, post-menopausal female, and volunteers who used any medications that could influence metabolic and inflammatory responses.
Bromelin, a Compound Prepared With Ananas Comocus Extract and Honey, for Acute Cough

Cough is the most bothersome symptom for patients with the common cold.

The objective of the study is to compare the phytotherapic "Bromelin", a compound preparation of honey from the bee apis mellifera with the extract of the pineapple (Ananas comosus) with placebo in reducing cough episodes in patients with the common cold.

Common cold is very frequent and cough is one of the most troublesome symptoms. Over-the-counter medications are used by patients without prescription, many times with important side effects.

Bromelin, a compound made with honey and pineapple extract could offer cough symptomatic relief as a soothing agent.

This study aims to compare this compound with placebo in reducing cough in patients with common cold in an clinical trial designed in conformity to CONSORT guidelines.

Eligibility Criteria:
Inclusion Criteria:

* cough for less than 24 hours
* common cold symptoms : nasal obstruction, headache, myalgias, runny nose.

Exclusion Criteria:

* declared chronic pulmonary diseases declared Nervous diseases declared Diabetes declared cardiac diseases known primary or secondary immunodeficiencies
Evaluating the Relationship Between Stress, Ethnicity, and Blood Pressure

High blood pressure is a common health problem among people in the United States. This study will examine the ways that stress and ethnicity play a role in the development of high blood pressure.

High blood pressure affects nearly one third of all people in the United States. It can be caused by many factors, including obesity, sodium intake, genetics, and stress. Ethnicity appears to also play a role, because African Americans are more susceptible to developing high blood pressure than other ethnic groups, with more than 40% of African Americans diagnosed with this condition. This study will examine the underlying reasons of why stress and African-American ethnicity contribute to high blood pressure risk and how ethnicity and stress interact with each other to increase this risk. Specifically, study researchers will examine how stress increases blood pressure, how people from different ethnic groups respond to stress differently, and how sleep plays a role in regulating blood pressure levels.

This study will enroll African Americans and Caucasians who have high blood pressure, as well as African Americans and Caucasians who have normal blood pressure. Potential participants will go through a screening process that involves a medical history review, questionnaires, and blood pressure monitoring. Eligible participants will then be admitted to the research clinic for a 2-night stay. Participants' nutrition history and body measurements will be obtained, and a catheter will be inserted into the arm so that blood can be easily collected during the clinic stay. During the night, participants' breathing habits and movements will be monitored while they sleep. During the day, blood pressure and heart activity will be monitored frequently, including when participants are asked to perform mildly stressful tasks, such as giving a short speech. Various medications that affect heart rate and blood pressure will be given at different times during the study, and researchers will monitor participants' reactions to each medication. Lastly, participants will also complete psychological questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Self-identifies as African American or Caucasian
* Weighs 85% to 150% of ideal weight (approximate BMI of 17.5 to 30)
* In good physical health

Exclusion Criteria:

* Blood pressure greater than 180/110 mm Hg at any point in the past
* Currently works less than half-time
* Currently is employed doing shift work
* Currently takes prescription medication, other than anti-hypertensive medication
* Currently smokes
A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.

This is a Long-Term, Single-Arm, Open-Label, Multicenter Phase 3 follow-on trial of the ARGX-113-1704 study to evaluate the safety and tolerability of ARGX-113 in patients with gMG. Patients who have completed at least 1 cycle of treatment and at least 1 year of trial ARGX-113-1705 and have started Part B are eligible to enroll in the open-label trial ARGX-113-2002 to receive efgartigimod by SC administration.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
2. Patients who participated in trial ARGX-113-1704 and are eligible for roll over, as specified in the protocol.

Other more specific inclusion criteria are further defined in the protocol.

Exclusion Criteria:

1. Patients who discontinued early from trial ARGX-113-1704 or patients who discontinued early from randomized treatment for pregnancy or rescue reasons or an (S)AE that might jeopardize the safety of the patient in that trial.
2. Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing. Women or childbearing potential should have a negative urine pregnancy test at SEB.
3. Male patients who are sexually active and do not intend to use effective methods of contraception during the trial or within 90 days after the last dosing or male patients who plan to donate sperm during the trial or within 90 days after the last dosing.
4. Patients with known Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) seropositivity.

Other, more specific exclusion criteria are further defined in the protocol.