cyrilzakka/clinical-trials huggingface dataset:
Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy

To compare the effectiveness of lens extraction combined with goniosynechialysis and trabeculectomy in treating advanced angle-closure glaucoma.

Advanced angle closure glaucoma (AACG) can result in severe visual function defect or even blindness with or without acute attacks. Different from open angle glaucoma (OAG), the main principle of treatment for AACG is not only to lower intraocular pressure (IOP) but also to protect the anterior chamber angle from closing. Previously, the most common and classical treatment for AACG was trabeculectomy. However, both doctors and patients are not satisfied with this surgery because of its limited success rate due to fibrosis of the filtration pathway. Besides, trabeculectomy has various complications, such as shallow anterior chamber, choroidal effusion, suprachoroidal hemorrhage, malignant glaucoma, and bleb leakage associated endophthalmitis. In addition, patients who underwent trabeculectomy will have decreased visual acuity in a couple of years due to accelerated development of cataract. Since a thickened and anterior-positioned lens could play a crucial role in the pathogenesis of AACG, cataract surgery has also been used. Accumulative evidence shows lens extraction alone is an efficient way in treating the early stage of ACG but has limited success rate in AACG. Lens extraction combined with goniosynechialysis (LEG) has been proved to be better than lens extraction alone in re-opening the anterior chamber angle for ACG patients with extensive peripheral anterior synechia and possibly have better effect than trabeculectomy as well from our preliminary data, which has not been proved yet. Thus, this investigation is designed to compare the effect of LEG and trabeculectomy in AACG patients prospectively in 3 years of follow-up. The investigators hypothesize that LEG could have better IOP control and better visual function than trabeculectomy in long term for AACG patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 40 years old to 80 years old
2. more than 180-degree synechial closure of anterior chamber angle on gonioscopy
3. IOP higher than 21mmHg under the use of more than two anti-glaucoma eye drops
4. mean deviation of visual field worse than -12dB on Humphrey 24-2
5. phakic eyes

Exclusion Criteria:

1. Snellen visual acuity worse than 0.02
2. history of ocular trauma
3. uveitis
4. previous ocular surgeries
5. significant conjunctival scar
6. visible neovascular on iris or anterior chamber angle
7. other severe eye diseases that would affect visual function significantly, such as age-related macular degeneration and pathogenic myopia.
Pandemic-Proofing Simulation-based Education

The goal is to develop and evaluate two VR simulations (interactive VR, 3600 video) applied to the context of Emergency Medicine. The aim of this pilot study is to develop two VR simulations, and to compare their effectiveness with traditional theatre-based simulations.

Primary Objectives: to compare knowledge retention and application of knowledge during emergency crisis scenarios following VR-360, interactive VR and theatre-based simulation sessions.

Secondary Objectives: to assess the usability and feasibility (resources), as well as the emotional engagement, of the above three modalities.

Phase 1: Creation of Content: A software engineer with expertise in video-game development will be hired to develop the computer-generated emergency department in collaboration with the educators and clinicians on the team. A theatre-based trauma scenario from the current uOttawa Emergency Department curriculum will be adapted to the VR platform. This virtual environment will allow a team of students to manage a patient simultaneously through their avatars, from a first-person perspective. In parallel, the same scenario will be scripted, in all its permutations, and recorded using a 360-degree HD video camera. The recording will be made using the investigators as actors, with additional interprofessional volunteers recruited as needed. These videos will be edited and then converted to an application that can be uploaded to the Oculus platform. Both platforms will undergo piloting for content and usability. The amount of time, money and other resources required to develop each of these scenarios will be calculated.

Phase 2: Evaluating the intervention:

Pre-test: Prior to participating in one of the 3 educational interventions, participants will complete a pre-test of their content-specific knowledge and knowledge application with respect to trauma resuscitation. As well, they will participate in a video-recorded in-situ simulation of a trauma resuscitation. Team performance will be recorded for subsequent scoring (see measures and analysis section below). During the in-situ sessions, the investigators will measure the learners' heart rate (HR) and heart rate variability (HRV) with the use of a Polar H10 chest belt linked with a commercial capture and analysis software program on an iPad. This will allow us to measure both arousal and stress responses, as physiological indication of the learners' emotional engagement.

Intervention: Following the pre-test, residents will either participate in the interactive VR, the 360o video or the in-person theatre-based simulation sessions.

Post-test. Two weeks after the education session, all participants will complete a post-test of their knowledge and knowledge application (matched in difficulty with pre-test), as well as lead an in-situ simulated trauma resuscitation. The sessions will be videotaped for subsequent rating of clinical and team performance.

Eligibility Criteria:
Inclusion Criteria:

Participants will be residents or medical students

Exclusion Criteria:

Anyone who is not a resident or medical student
Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome

The purpose of this study is to determine presence of central adrenal insufficiency in children with Prader Willi Syndrome using low dose (1 mcg) ACTH stimulation test compared to results of overnight metyrapone test.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with Prader Willi Syndrome ages 2 years and older

Exclusion Criteria:

* Individuals who are ill at the time of study
* Individuals who are pregnant at the time of study
* Individuals who it is deemed unsafe to stop taking medications known to affect the results of they study (hydrocortisone, phenytoin, estrogen, acetaminophen, oral anti-diabetic agents).
Resistance Training for Patients Diagnosed With External Snapping Hip

The purpose of this study is to investigate whether targeted progressive resistance training is safe and feasible for patients with external snapping hip. Dropout rates, adverse events and training adherence are investigated. The secondary purpose is to investigate whether it is possible through targeted progressive resistance training to improve participants' muscle strength, functional status and hip-related quality of life.

Snapping hip (coxa saltans) is a disorder where the hip tends to make an audible click-through movement, often but not necessarily associated with pain. A prevalence of 5-10% of the general population has been reported. Snapping hip is divided into three forms of snapping hip; intraarticular, internal and external snapping hip. External snapping hip (coxa saltans external) is the most common form, and patients may experience pain when the iliotibial band or anterior part of the gluteus maximus slides over the greater trochanter at femur. Patients with external snapping hip are typically between 15 and 40 years, and physically active.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Greater Trochanteric Pain Syndrome at the Orthopedic Surgery Department at Aarhus University Hospital in the period 2013-2015. In case of too few participants from this sample, we plan to include patients diagnosed during 2018
* Minimum 18 years old
* Able to read and understand Danish
* Have experienced jump/click from the outside of the hip associated with pain within the last 14 days
* Have a residence of a maximum of 55 km from Aarhus C
* The participants must not have participated in regular resistance training of the hip muscles for more than 1 day per week in the last 6 months leading up to the start of the intervention
* The participants must not have undergone a total hip replacement, a Periacetabular Osteotomy, a Z-plastic surgery or arthroscopy in the hip within 6 months before the start of the intervention or have a planned hip surgery during the intervention period
* The participants must not suffer from neurological, rheumatological, metabolic or respiratory diseases that will influence the effect of the intervention
* The participants must not have a planned vacation lasting more than 14 days during the intervention period, while not having the opportunity to extend the training period accordingly

Exclusion Criteria:

* BMI \>40
* No longer suffering from external snapping hip
* Pregnancy
The Effect of Phentermine and B12 on Weight Loss Among Obese Patients

This is a pilot study designed to test the hypothesis that the combination of phentermine and B12 will result in significantly greater weight loss among obese patients compared to phentermine alone.

This pilot study is a double blind, randomized controlled trial designed to determine the significance of the combination therapy of phentermine and B12 injections among the obese population. The study population will be recruited from the ECU Physicians Internal Medicine clinic. Physicians will select patients meeting inclusion and exclusion criteria from their clinic to be approached for recruitment. Approximately 30 patients will be recruited and blindly randomized to either the treatment group (phentermine and B12 in combination) or the control group (phentermine alone). Patients will be randomized by means of block randomization in a 1:1 ratio. Neither patients nor study team members will be aware of group assignments through the entire duration of the study. Once randomized, both groups will begin taking 37.5 mg/day orally of phentermine as well as receive weekly intramuscular injections of either 1000 mg B12 or Saline depending on their group assignment. The study will consist of approximately 15 visits over the course of 3 months.

Eligibility Criteria:
Individuals can participate in the study if they meet the following inclusion criteria:

* Are over the age of 18
* Have a BMI between 30 and 40
* Have a controlled blood pressure
* Do not have a B12 deficiency
* Are willing to take birth control (if female and not sterile or through menopause)
* Are English speaking

Individuals should not participate in if any of the following apply to them:

* Are not over the age of 18
* Do not have a BMI between 30 and 40
* Do not have a controlled blood pressure
* Have a B12 deficiency
* Females who are pregnant, trying to get pregnant, or not willing to use a method of birth control to ensure they do not become pregnant
* Individuals who do not speak English
* Individuals currently taking Adderall, Ritalin, or any other stimulant medication
* Individuals who have taken phentermine more than once in the past, or within 3 months of study initiation
A Study of Potential Drug-Drug Interaction Between Efavirenz and Danoprevir With Low Dose Ritonavir in Healthy Volunteers

This phase 1, randomized, open-label, multiple-dose, 2-sequence, 2-period crossover study will evaluate potential drug-drug interaction between efavirenz and danoprevir with low-dose ritonavir in healthy volunteers. In Period 1. subjects will be randomized to receive multiple oral doses of either danoprevir with ritonavir or efavirenz for 14 days. In Period 2, all subjects will receive multiple oral doses of the combination danoprevir with ritonavir and efavirenz for 14 days. Anticipated time on study treatment is 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female non-smoking subjects, 18 to 55 years of age
* Healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
* Medical history without major, recent or ongoing pathology
* Weight \>/= 50.0 kg
* Body mass index (BMI) 18.0 - 32.0 kg/m2

Exclusion Criteria:

* Pregnant or lactating women or males with female partners who are pregnant or lactating
* History of any clinically significant medical condition which may impact the safety of the participant
* Positive results for drugs of abuse at screening or prior to admission to the clinical site during any study period
* Positive for hepatitis B, hepatitis C or HIV infection
* Current smokers or subjects who have discontinued smoking less than 6 months prior to first dose of study medication
* Use of hormonal contraceptives (e.g. birth control pill, patches, or injectable, implantable devices) within 30 days before the first dose of study medication
* Use of investigational drug or device within 30 days of the first dose of study medication (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer
* History of drug-related allergic reaction
* History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average; alcohol consumption will be prohibited 72 hours prior to entry in the clinical site center and throughout the entire study
Study of NST-6179 in Healthy Subjects

A double-blind, randomized, placebo controlled, single and multiple oral dose study to assess safety and tolerability of single and multiple doses of NST-6179 in healthy male and female subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females, of any race, between 18 and 65 years of age, inclusive.
2. Body mass index between 18.0 and 32.0 kg/m\^2, inclusive.
3. In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and/or check in as assessed by the investigator (or designee).
4. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
5. Able to comprehend and willing to sign an ICF and to abide by the study restrictions

Exclusion Criteria (additional criteria available):

1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
2. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
3. Any of the following:

   1. QT interval corrected for heart rate using Fridericia's method (QTcF) \> 450 ms confirmed by repeat measurement.
   2. QRS duration \> 110 ms confirmed by repeat measurement.
   3. PR interval \> 220 ms confirmed by repeat measurement.
   4. findings which would make QTc measurements difficult or QTc data uninterpretable.
   5. history of additional risk factors for torsades de pointes (eg, heart failure, hypokalaemia, family history of long QT syndrome).
4. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the investigator (or designee).
5. Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing, unless deemed acceptable by the investigator (or designee).
6. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing.
7. Vegetarians, vegans, and/or unable to consume the high fat breakfast (subjects participating in a food effect evaluation only).
8. History of alcoholism or drug/chemical abuse within 2 years
Microparticles in Pediatric Inflammatory Disease

The purpose of this study is to provide data correlating levels of microparticles that circulate in the blood and disease activity in children with inflammatory bowel disease (IBD). The hypothesis is that circulating microparticles will be higher in children with active IBD, show inflammatory activity, and will be low in patients in remission as well as in healthy controls.

Once the response of microparticles to inflammation is defined in this patient population, the microparticles can be used as biomarkers of disease activity and could potentially use microparticles as targets of therapeutic agents.

This cross sectional study will enroll 15 Crohn's patients (5 inactive, 5 mild, 5 moderate-severe disease based on the pediatric Crohn's disease activity index), 15 Ulcerative Colitis patients (5 inactive, 5 mild, 5 moderate-severe disease based on the pediatric ulcerative colitis activity index), and 10 healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Children with IBD based on endoscopic, histologic, radiologic, or laboratory data
* Ages between 8 and 17 years old

Exclusion Criteria:

* Anyone with a concurrent illness since infection can affect microparticle levels
Endovascular NeuromoDulation Treatment fOr Heart Failure Patients (ENDO-HF)

The purpose of the ENDO-HF study is to determine the safety \& performance of the Harmony System for the treatment of heart failure


Eligibility Criteria:
Inclusion Criteria:

* Subject is diagnosed as chronic heart failure NYHA class II-III
* Subject should be receiving optimal medical treatment
* Subject signed and dated informed consent

Exclusion Criteria:

* Subject has severe aortic sclerosis or calcification
* Subject diagnosed with severe aortic valve disease
* Subject has severe mitral stenosis
* Subject involved in any concurrent clinical investigation
* Subject with cerebral vascular accident or transient ischemic attack prior to enrollment
* Subject diagnosed with Marfan Syndrome
* Subject with moderate or severe chronic obstructive lung disease
* Subject is allergic to iodine or contrast media
* Subject with prior cardiac transplant or heart transplant candidate
* Subject with a life expectancy of less than 12 months
Dietary Assessment and Prevention of Hypertension in Nigeria

Contrary to North America and Europe, the prevalence of hypertension is rising in West Africa and, currently, there are no simple dietary assessment tools for clinicians to offer personalized dietary support to their patients. This study aims to:

1. Evaluate the feasibility and validate the a short dietary screening tool for hypertension for use in Nigerian clinics; and
2. Test the accuracy and estimate the potential value of the validated short dietary assessment tool in Nigeria clinics.

Contrary to North America and Europe, the prevalence of hypertension is rising in West Africa. With a transition from whole foods to processed foods in Nigeria, diet is considered a key driver of hypertension. To combat this, the national nutritional guidelines in Nigeria were implemented but their translation into actionable tools for clinicians remains a challenge. Currently, there are no simple dietary assessment tools that are concise and suitable to be incorporated into clinical care without requiring extensive data analysis while still providing personalized dietary support to their patients. This study aims to deliver a clinically tested and validated short dietary assessment tool for clinicians, patients, and researchers across Nigeria to provide personalised dietary advice for patients with hypertension.

The study will be conducted in two phases: Phase 1 (n=75), will investigate the feasibility of the short FFQ and its agreement with 24-hour dietary recalls (3x) in a clinical setting in Nigeria. During the analysis of Phase 1 data, a scoring system will be developed based on the associations between individual food items in the FFQ and measures of hypertension. Phase 2 (n=50) will assess the acceptability of the FFQ and validate the association between the FFQ score and hypertension.

We anticipate that the development of a clinically tested and validated short food frequency questionnaire that will be ready for implementation analysis for use by clinicians, patients, and researchers across Nigerian that will support the prevention and management of hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Men and women of generally good health or with hypertension

Exclusion Criteria:

* history of chronic diseases such as cardiovascular diseases (heart diseases), stroke, chronic kidney diseases, or pregnant or breastfeeding women, children below 18 years and adults above 70 years are also excluded from this study. Additionally, individuals who have made significant changes to their diet in the past six months or are currently following specific dietary restrictions will also be excluded from this study
Evaluation of Functional Orthodontic Treatment on Sleep Quality

Functional appliances are used in the treatment of Class II anomalies caused by mandibular rethrognathia. Herbst which is a fixed and rigid functional appliance and TWB which is removable appliance can be successful in the treatment of mandibular retrognathia in a short period of six to eight months during the pubertal growth phase. An increase in the upper airway size occurs as a result of functional orthopedic treatment devices eliminating the problem of mandibular retrognathia and stimulating mandibular growth. The aim of this randomized controlled trial was to evaluate the effects of TWB and Herbst appliances on sleep quality in children with obstructive sleep apnea. The null hypothesis was that there is no difference for the sleep quality between the appliances.

Introduction: This multicenter clinical study aimed to investigate the effects of twin block (TB) and Herbst functional appliances on sleep quality in children with OSAS and mandibular retrognathia. Methods: A total of 46 patients having mandibular retrognathia and identified with OSA were divided randomly into two groups: twin block (TB) and Herbst functional appliances. Changes in sleep parameters at baseline and an avarage of 8-month follow-up detected by polygraphy and Pittsburg Sleep Quality Index (PSQI) were the primary outcome. Treatment of the mandibular retrognathia was the secondary outcome. hapiro Wilk test and Q-Q graphs were used to examine the distribution assumptions of continuous variables according to groups. Mann Whitney U test was used to evaluate two independent group means or distributions of continuous measurements. Paired sample t test or Wilcoxon signed rank test was used to evaluate the differences between the baseline and follow-up times at p \< 0.05 significance level.

Eligibility Criteria:
Inclusion Criteria:

* no prior orthodontic treatment, nasal, tonsillar, or adenoid surgery
* absence of any oral, nasal or systemic disease
* the existence of skeletal Class II and dental Class II Division 1 malocclusion (ANB \>4°; SNB \<80°; incisor overjet \>3 mm)
* requiring functional orthodontic treatment
* Individuals are in the MP3cap and S period according to hand-wrist films, and in the CS3 and CS4 period using the CVM method
* patients with OSA (apnea/hypopnea index (AHI)\>1/h

Exclusion Criteria:

* body mass index (BMI) ≥ 30 (weight (kg)/height (m2))
* the presence of nasopharyngeal pathologies, craniofacial anomalies, , systemic disorder, or weak oral hygiene
* history of previous orthodontic treatment