cyrilzakka/clinical-trials huggingface dataset:
Effect of Novel Nasoalveolar Molding Techniques on Parents' Satisfaction and Short Term Treatment Outcomes in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial

The aim of this trial is to figure out the efficiency of modified Grayson NAM on parents' satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. NAM might improve and facilitate the surgical procedure after lip closure. This might decrease the need of further interventions to improve esthetics and function of CLP patients. This trial will help the patients and practitioners in taking the decision of inclusion of NAM in the CLP treatment protocol as a mandatory step or skip a useless procedure with all of its burden.

In this randomized trial, 4 groups will be included. The first group will receive a modified nasoalveolar molding appliance in addition to taping. In the second group, the patient will receive the CAD/NAM. the third group is tape only, while the fourth group remain untreated. the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, photographs for nasal esthetics and interlabial gap outcome and maxillary models for the maxillary dimension change outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Infants with age range from 7 - 30 days.
2. Unilateral complete cleft lip and alveolus.
3. Presence of unilateral cleft palate.
4. Medically free subjects.
5. Both males and females.

Exclusion Criteria:

1. Patients older than 30 days.
2. Syndromic patients with other defects in addition to cleft lip and palate.
3. Patients with bilateral cleft lip and palate.
4. Incomplete Cleft lip.
5. Medically compromised patients.
Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy

To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Amyotrophic Lateral Sclerosis Patients with gastrostomy


Eligibility Criteria:
Inclusion Criteria:

The key criteria are listed below.

* Patients aged between 20 and 80 years at the time of informed consent
* Japanese patients
* Among patients with ALS, those "Clinically definite ALS," "Clinically probable ALS" or "Clinically probable-laboratory-supported ALS" according to El Escorial Revised Airlie House criteria
* ALS Patients with gastrostomy
* Patients who can consent to contraception
* Patients who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study

Exclusion Criteria:

The key criteria are listed below.

* Patients in whom the possibility could not be ruled out that the current symptoms were symptoms of a disease requiring differential diagnosis, such as cervical spondylosis and multifocal motor neuropathy
* Patients undergoing treatment for malignancy.
* Patients who have presence of clinically significant liver, heart, or renal disease requiring hospitalization (except ALS) and infections requiring antibiotics. Patients who have a problem in general condition and are judged ineligible by the Investigator
* Body mass index (BMI) of \<15.0 or \>30.0, or a body weight of \<40 kg
* Patients judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason
Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Department of Anesthesia At PHC

To confirm feasibility and accessibility of the CCPC Platform (Oxymotion, Bridge Health Solutions medication adherence software, CloudDX home kit) in two different environments - in hospital and at-home, in patients undergoing non-cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* 19 years or older
* Patients that have undergone a non-cardiac surgery at SPH requiring an inpatient hospital stay
* Peri-op patients who are in the Surgical High Acuity Unit (SHAU) and those followed by Anesthesia Perioperative Outreach team on the ward
* Living within British Columbia, Canada and in an area that is covered by Bell cellular network

Exclusion Criteria:

* Patient refusal
* Lack of capacity to consent to the study (including having received sedative or general anesthetic within the past 24 hours)
* Unable to use (or does not have a caregiver who can help put on) study monitoring device at home
* Unable to complete (or does not have a caregiver who can help complete) study questionnaires by electronic (mobile, tablet, or computer), paper, nor phone
* No access to cell phone nor landline at home to receive follow-ups
* Preoperatively known to be discharged to a nursing home or rehabilitation facility
* Known allergic reactions to any part material of study devices
Olanzapine 2.5 vs 5 mg in Quadruplet Nausea/Vomiting Prophylaxis Before High-Dose Melphalan

Patients who receive a chemotherapy called melphalan are at high risk of having nausea and vomiting. A medication called olanzapine has been shown to decrease nausea and vomiting after chemotherapy. A previous research study found the 10 mg dose of olanzapine (combined with 3 standard medications used routinely to prevent nausea/vomiting) to be effective for patients who received melphalan chemotherapy, but several other studies have shown many patients have a side effect of sleepiness (e.g., sedation) with that dose of the medication. Our study will compare two lower doses of olanzapine (5 mg and 2.5 mg) in combination with the 3 standard medications used to prevent nausea/vomiting in the patients who receive melphalan chemotherapy to determine which dose is effective in preventing nausea and vomiting with the lowest amount of sleepiness side effect.

This study is a randomized, double-blinded trial comparing olanzapine 2.5 mg vs 5 mg in combination with standard triplet antiemetic prophylaxis in patients with multiple myeloma who are receiving high-dose melphalan conditioning chemotherapy before autologous stem cell transplantation to determine chemotherapy-induced nausea and vomiting (CINV) and sedation outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Receipt of high-dose melphalan 140-200 mg/m2
* Autologous stem cell transplantation recipient

Exclusion Criteria:

* Allergy to olanzapine
* Documented nausea or vomiting within 24 hours prior to enrollment
* Treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone within 30 days prior to enrollment or planned during protocol therapy
* Chronic alcoholism
* Pregnant
* Decline or unable to provide informed consent
Regional or General Anesthesia for Carotid Endarterectomy in Patients With Acute Stage of Ischemic Stroke.

The study is planned to evaluate the effectiveness and safety of two types of anesthesia (regional and general) for carotid endarterectomy in 100 patients with acute stage of stroke: 50 patients will be operated under regional anesthesia and the remaining 50 patients under general anesthesia.

Patient inclusion criteria:

1. Ischemic stroke in the middle cerebral artery territory
2. Ipsilateral stenosis of the internal carotid artery more than 50%
3. Neurological deficit at the time of surgical treatment: the modified Rankin scale (mRs) score of 0-4 and the US National Institutes of Health (NIHSS) stroke scale score no more than 12
4. The size of the ischemia focus: no more than 1/3 in the territory of the middle cerebral artery brain supply
5. Terms of operation: from 1 to 28 days from the moment of ischemic stroke

The primary intra-hospital and/or 30-day study endpoints:

1. Perioperative ipsilateral ischemic stroke.
2. Any stroke: contralateral ischemic or any hemorrhagic stroke.
3. Myocardial infarction.
4. Hemorrhagic complications that required surgical revision of the operating wound or transfusion of blood components.
5. Surgical site infection
6. Death
7. Main adverse cardiovascular events (stroke + myocardial infarction + death).


Eligibility Criteria:
Inclusion Criteria:

* 1. Ischemic stroke in the middle cerebral artery territory 2. Ipsilateral stenosis of the internal carotid artery more than 50% 3. Neurological deficit at the time of surgical treatment: the modified Rankin scale (mRs) score of 0-4 and the US National Institutes of Health (NIHSS) stroke scale score no more than 12 4. The size of the ischemia focus: no more than 1/3 in the territory of the middle cerebral artery brain supply 5. Terms of operation: from 1 to 28 days from the moment of ischemic stroke

Exclusion Criteria:

-
Functional Imaging of Social Cognition in Premanifest Huntington's Disease

Huntington's disease (HD) is a genetic progressive fatal neurodegenerative disorder. In the western world it affects 5-10 persons per 100000. The main brain changes include the loss of brain cells in subcortical structures. The symptoms of HD include involuntary movements, cognitive deterioration and behavioural disturbances. It has been shown that changes in emotion comprehension occur before the onset of the motor symptoms (preHD). This deficit in perception of emotions has been primarily investigated by means of facial expressions. However, emotions can also be expressed through body language. Here, the investigators propose to investigate whether the emotion comprehension deficit in preHD also includes body language comprehension.

The investigators will perform a detailed evaluation of body language comprehension abilities in persons that carry the genetic mutation causing HD, but who do not show any movement symptoms yet. In addition, the associated changes in brain structure and function will be studied. The aim is to perform the study with the same group of participants who participated in a recent study carried on by this research group, in which the functional brain changes associated with increased irritability were investigated. This will allow to relate emotion experience with emotion perception. The results of the study may provide a target to further develop therapeutic interventions and aid caregivers of preHD subjects.

Eligibility Criteria:
Inclusion Criteria:

* Huntington's disease positive genotype and non-carrier siblings

Exclusion Criteria:

* visible chorea
* MRI contra-indications
* major neurological/psychiatric comorbidity
Evaluation of Eye Health Benefits of Blueberry Chewable Tablets

To assess the efficacy of blueberry chewable tablets on Eye Health


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women over 20 years old
* Use 3C products over 6 hours per day
* Symptoms of dry eyes or tired eyes
* Tear Break-Up Time is 10 seconds less
* No history of ocular surgery (strabismus surgery, refractive surgery etc.)

Exclusion Criteria:

* Have systemic diseases affecting the front surface of the eyes.
* Long-term use of drugs or eye drops that affect the condition of the front surface of the eyes
* Long-term contact lens wear
Assessment of MDD Management in Andalusia

The main objectives of this study are to describe medical professionals responsible of the management of patients with MDD in a representative region of Andalusia (in terms of type of sites managing the disease, and referral to SC criteria); Describe MDD patient characteristics at inclusion in the PISMA-Ep Study; and to evaluate those factors associated to a higher incidence of referral from PC to SC.

Assessment of MDD management strategies in Andalusia: A Sub-analysis of the PismaEP Study

Eligibility Criteria:
Inclusion Criteria:

* MDD Diagnosis Participants of the PismaEP study 18 yo. or older

Exclusion Criteria:

* No specific exclusion criteria
The Effect of Intravenous Fentanyl Prior the End of Surgery on Emergence Agitation in Paediatric Patients After General Anesthesia

The propose of this study is to determine the effect of intravenous fentanyl prior the end of surgery on the incidence and severity of EA in pediatric patient.

Emergence agitation (EA) is a common self limiting problem after emerging from general anesthesia (GA) especially in pediatric patients. The incidence of EA in Thai population, the incidences of EA 43.2% in pediatric patients aged between 2-9 years. There have been many studies tried to reduce the incidence of EA in various ways such as Preoperative anxiety reduction method and medication. Premedication, Sedative drugs and narcotic drugs were used to reduce the incidence of EA.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 2-9 years
* IPD patient
* Receiving Chloral hydrate 50mg/kg (BW\<20 kgs)or midazolam 0.1 mg /kg (BW\>20 kgs)Per oral for premedication
* Scheduled for one kind of these surgeries; Otolaryngology, Ophthalmology, Urology, Orthopedic,General surgery, Plastic surgery and Cardiac catheterization.

Exclusion Criteria:

* ASA physical status IV-V
* History of drug allergy:thiopental, fentanyl cisatracurium, chloral hydrate and diazepam
Validation of Epworth Richmond's Echocardiography Education Focused Year

The use of echocardiography in intensive care is a developing field. In expert hands echocardiography has proven its utility in diagnosing cardiac pathology, differentiating shock states and in haemodynamic monitoring. However, whether the results obtained by experts can be generalized to trainees or specialists with limited training remains unclear. Further, concerns around training time and cost for intensive care staff have been a factor in limiting the uptake of echocardiography in intensive care.

The investigators aim to assess the diagnostic accuracy of Australian ICU doctors in training after completion of the current minimum training. After completing a structured teaching program and 30 mentored training scans trainees will be assessed on their accuracy with echocardiography. In the research phase trainees will complete a further 40 scans with each one matched with an expect scan. The results from the expert and trainee scans will be compared to determine the trainee's accuracy.


Eligibility Criteria:
Registrar Inclusion:

* At least 12 month appointment in Epworth Richmond ICU
* Completion of theoretical component of Epworth Richmond ICU echocardiography program
* Completion of 30 echocardiography scans

Registrar Exclusion:

• Previous experience in echocardiography prior to commencing at Epworth Richmond.

Patient Inclusion

* Patient in ICU or CCU
* 18 years or older
* Not likely to be discharged before completion of the scan

Patient Exclusion

* Likely to be discharged within next two hours
* Atrial fibrillation
* Presence of subcostal or intercostal drains or pneumothorax
* Unable to be consented
* Treating intensivist deems inclusion in study not suitable.
Influence of Standardized Perioperative Anesthetic, Analgesic Care on Outcome of Patients Undergoing Hip Fracture Surgeries

The purpose of this voluntary research study is to clarify whether or not a single injection nerve block done before surgery and after surgery nerve block catheter can effectively enhance recovery in elderly hip fracture patients in terms of reduced delirium, reduced length of stay and improved surgical and anesthesia outcomes. Delirium is a serious change in mental abilities. It results in confused thinking and a lack of awareness of someone's surroundings. The disorder usually comes on fast - within hours or a few days. Prolonged hospital stay is one of the risk factors for onset of delirium.


Eligibility Criteria:
Inclusion Criteria:

1. Undergoing anesthesia for hip fracture surgery.
2. Patients with fracture neck of femur fractures.
3. Geriatric patients. (65 years and older)

Exclusion Criteria:

1. Non-fracture hip patients
2. non-geriatric patients. (Below 65 years old)
3. Patients not able to consent themselves
4. Non- English-speaking patients
Diagnostic Interview and One-session Cognitive Therapy in Treatment of Dental Fear

Clinical trial of an application of cognitive behavioural one-session therapy method with patients who have severe or average dental fear/anxiety measured by Modified Dental Anxiety Scale (MDAS). The intervention consists of two different parts: a diagnostic interview and one-session treatment of dental care. The method is based on One-Session Therapy manual (Öst \& Skaret, 2013). 30 minimum 18 years old adults takes part to the study. They comes from three different places,primary care clinic, community dental care and dentist´s teaching clinic.

Purpose is to compare diagnostic interview (n=20) to diagnostic interview and one-session treatment of dental care (n=10). Partners come from three different places, 10 from each: public and private dental care and dental school. Participants from dental school take part to one-session treatment. All participants have normal dental care before final interview. Hypotheses is that dental fear/anxiety will decrease one category (5 points) when measured by Modified dental anxiety scale (MDAS) before the intervention and after normal dental care. Visual Analogue Scale is used to measure the strength of unpleasant feeling before and after intervention in both groups.

Eligibility Criteria:
Inclusion Criteria:

* MDAS 13 or over, dental care in normal circumstances doesn´t work, motivation to treat dental fear, minimum 18 year

Exclusion Criteria:

* Mental disorder, dementia, pregnancy, acute state of somatic illness
Study of FibroGen (FG)-3019 in Subjects With Type 2 Diabetes Mellitus and Kidney Disease on ACEi and/or ARB Therapy

The purpose of this study is to evaluate the effect of FG-3019 on diabetic kidney disease or diabetic nephropathy.

The primary objective of this study is to assess the effect of FG-3019 on proteinuria as assessed by urinary albumin/creatinine ratio (ACR).

Eligibility Criteria:
Key Inclusion Criteria:

1. Signed written informed consent
2. Males and females 18-75 years of age, inclusive
3. Diagnosis of type 2 diabetes mellitus according to American Diabetes Association (ADA) criteria
4. 24-hour urinary ACR 200-3000 mg/g, inclusive, on two occasions during screening at least 2 days apart
5. Estimated glomerular filtration rate (eGFR) (by MDRD equation) \>20 mL/min/1.73 m2
6. Mean systolic blood pressure less than or equal to 150 mmHg and a mean diastolic blood pressure less than or equal to 95 mmHg
7. Receiving ACEi and/or ARB therapy at an unchanged dose at or above the minimum trial dosage for at least 3 months prior to the first Screening visit and willing to maintain these doses throughout the treatment period

Key Exclusion Criteria:

1. Females who are pregnant or breast feeding
2. Organ transplant recipient, history of dialysis, or known non-diabetic renal disease other than benign cysts or anatomical variants
3. History of New York Heart Association class III/IV heart failure
4. Screening electrocardiogram showing acute and/or clinically significant findings including but not limited to ST depression
5. History of any of the following events within 3 months prior to Screening: coronary artery bypass graft, cerebrovascular accident, myocardial infarction, transient ischemic attack, unstable angina, uncontrolled cardiac arrhythmia, atrial fibrillation, percutaneous coronary intervention, or vascular stent placement
6. History of anaphylactic or systemic allergic reaction to human, humanized, chimeric, or murine monoclonal antibodies
7. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>2.5 times the upper limit of normal; direct bilirubin above the upper limit of normal, or \>2.5 times the upper limit of normal in cases of documented Gilbert's syndrome
8. Hemoglobin \<10 g/dL
9. Hemoglobin A1c (HbA1c) \>9 %
10. Low density lipoprotein (LDL) \>130 mg/dL
Occupational Performance Coaching in Mothers of Children With Cerebral Palsy

A single-blind Randomized Controlled Trial will be used to test the efficacy of the OPC on self-efficacy and occupational performance with mothers of children with cerebral palsy. Canadian Occupational Performance Measurement and Sherer general self-efficacy scale will be employed to data collection. The sample size was determined for each group of 15 people. The participants conveniently and according to inclusion and exclusion criteria will be randomized into the groups. Participants in the intervention group will be participated in 10 sessions of OPC. At the end the questionnaires will be completed by both groups.


Eligibility Criteria:
Inclusion Criteria:

mothers: being literate 25 to 25 caring nobody disabled other than her child children: 5 to 12 cerebral palsy

Exclusion Criteria:

children: others problems that affect on communication
Whole Brain Vessel Wall Imaging in Stroke Patients (WISP): An International Multi-Center Registry

This is a new vessel wall imaging-based stroke registry which will investigate the clinical utility of the whole-brain intracranial vessel wall Magnetic Resonance Imaging (MRI) technique in assessing the etiologies in patients with ischemic stroke.

The registry will focus on investigating the utility of whole-brain vessel wall MRI techniques in assessing the etiologies in patients with recent ischemic stroke. Patients who have had ischemic stroke (as confirmed by diffusion weighted MRI) and have had or will undergo 3D whole-brain vessel wall MRI within 8 weeks of symptom onset will be recruited into this study. It is anticipated that a total of 1000 subjects will be recruited from Feb 2017 to Feb 2019. Approximately 12 centers in the US and China will participate in the registry. MRI whole-brain vessel wall images will be analyzed for detection and characteristics of various vessel wall pathologies and association between vessel wall imaging findings and patient's clinical information.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age
* Ischemic stroke onset within 8 weeks and confirmed by diffusion weighted MRI
* Ability to read and understand informed consent

Exclusion Criteria:

* The cause of stroke has been confirmed to be related to cardiac or extracranial carotid or aorta pathologies.
* Contraindications to MR imaging including mechanically, magnetically, or electrically activated implants, ferromagnetic implants and ferromagnetic foreign bodies, pregnancy.
* Inability to tolerate MRI imaging secondary to an inability to lie supine or severe claustrophobia.
* Non-compliant with visit instructions, including inability to lie still, hold breath or follow procedure instructions