cyrilzakka/clinical-trials huggingface dataset:
Using Machine Learning to Adapt Visual Aids for Patients With Low Vision

According to the WHO's definition of visual impairment, as of 2018, there were approximately 1.3 billion people with visual impairment in the world, and only 10% of countries can provide assisting services for the rehabilitation of visual impairment. Although China is one of the countries that can provide rehabilitation services for patients with visual impairment, due to restrictions on the number of professionals in various regions, uneven diagnosis and treatment, and regional differences in economic conditions, not all visually impaired patients can get the rehabilitation of assisting device fitting.

Traditional statistical methods were not enough to solve the problem of intelligent fitting of assisting devices. At present, there are almost no intelligent fitting models of assisting devices in the world. Therefore, in order to allow more low-vision patients to receive accurate and rapid rehabilitation services, we conducted a cross-sectional study on the assisting devices fitting for low-vision patients in Fujian Province, China in the past five years, and at the same time constructed a machine learning model to intelligently predict the adaptation result of the basic assisting devices for low vision patients.


Eligibility Criteria:
Inclusion Criteria:

* Low vision
* Aged 3 to 105

Exclusion Criteria:

* Severe systemic disease
* Failure to sign informed consent or unwilling to participate
Study of Clinic-based Versus Self-use of Medical Abortion Pills

The goal of the study is to determine whether important clinical outcomes differ among women who access a combined medical abortion regimen from a pharmacy when compared with those who access it from a facility.

Medical abortion with mifepristone and misoprostol within the first 10 weeks of pregnancy is safe and highly effective. Investigators aim to assess whether self-use of early (\<9 weeks) medical abortion using mifepristone with misoprostol results in non-inferior rates of clinical outcomes when compared with clinic-based provision of medical abortion.

The investigators will prospectively recruit women who obtain medical abortion medication from pharmacies and clinics. Follow-up will occur by telephone during two phone calls within 30 days following the woman's abortion. A small number of adolescents will be recruited into a qualitative substudy.

Eligibility Criteria:
Inclusion Criteria:

Women are eligible for participation if they have purchased abortion medications (mifepristone-misoprostol) independently at a pharmacy or received them from a clinic for an unwanted pregnancy at less than 9 weeks since her last menstrual period (LMP). She must meet the following criteria:

* Be at least 15 years of age (may vary by country)
* Have a known LMP of less than 9 weeks
* No contraindications to medical abortion (list)
* Willing and able to give informed consent
* Have a mobile phone of which they are the independent user or be willing to be followed-up in person
* Willing to be contacted with questions about her abortion by telephone (optional in-person visit) at 3, 10-14 and 30 days following initial contact.
* Resident of country of study.

Exclusion criteria:

* Contraindications to mifepristone-misoprostol
* Age \<15
Accuracy of Half of the Usual Radiotracer Dose in SPECT

There has been a shortage of nuclear isotopes, not only in Canada but around the world. New, more sensitive SPECT cameras can obtain better images in shorter scan times. These cameras have also shown the ability to use a smaller dose of radioisotope to obtain the images. New software has been tested on the standard camera, the GE Infinia-Hawkeye SPECT/CT. The Diagnostic Imaging Department of The University of Ottawa Heart Institute has also acquired a new camera, the Discovery NM530c CZT and has been doing heart scans in shorter times. The investigators will now be looking at the quality of images using less isotope during SPECT myocardial perfusion imaging for diagnostic and prognostic purposes.

SPECT MPI is well accepted as a reliable and cost-effective tool for diagnosis, risk stratification and management of patients with suspected or known coronary artery disease (CAD) (1;2). MPI represents approximately 40% of nuclear medicine patient studies and most of these use 99mTc-sestamibi or 99mTc-tetrofosmin(3). Rest/stress MPI using 99mTc-sestamibi and 99mTc-tetrofosmin uses more tracer doses than many other nuclear medicine tests and thus account for \>50% of injected radiotracer activity(3). Thus, interruptions in the supply of 99Mo, the parent isotope of 99mTc, significantly affect stress MPI imaging and associated patient care.

Alternatives to 99mTc-sestamibi and 99mTc-tetrofosmin for perfusion imaging include 201Tl for SPECT imaging and 82Rb or 13NH3 for positron emission tomography (PET) imaging (4;5). MPI using 201Tl has similar diagnostic accuracy but image interpretation is more difficult due to greater scatter and attenuation. Moreover, the patient effective radiation dose for MPI using a standard injected dose of 3.5mCi of 201Tl is \~20 mSv. This radiation dose is twice that of 99mTc tracers which typically deliver an effective dose of \~10 mSv. PET imaging with 82Rb or 13NH3 is another alternative, but is much more expensive and not routinely available in Canada due to a very limited install base of PET scanners and associated cyclotrons. The number of SPECT cameras operational in Canada is more than 40 times the number of PET scanners.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients presenting for clinically indicated SPECT perfusion scan
* Patients presenting to sites with a functional CZT camera. Available sites are Ottawa (OHI), Mississauga, and Calgary.
* Age \>18 years old

Exclusion Criteria:

* Patients with a life expectancy less than 1 year, from non cardiac cause
* Age \< 18 years old or lack of consent
* Allergy or contraindication to dipyridamole
* Refractory angina or infarction or need for urgent angiography
* Known pregnancy
* Uncontrolled atrial fibrillation
The Effects of Early Complementary Feeding on Growth, Neurodevelopment, Sleep and Gut Health

The overall objective of this project is to understand how consuming a prescribed diet of different infant foods (which may contain cereals,fruits, vegetables, meats, dairy) during the time of early complementary feeding (\~5 to 12 months) in breastfed infants has on growth trajectories, neurodevelopment and sleep patterns in relation to gut microbiota, compared with a traditional diet that is usually provided in the home to infants.

The three primary aims include:

Aim 1: Identify the effects that the prescribed early complementary feeding specific study diet has on growth trajectories in breastfed infants.

Aim 2: Identify whether the relationship between the prescribed early complementary feeding specific study diet and growth is mediated by gut microbiota.

Aim 3: Characterize infant neurodevelopment and sleep patterns.

Some details are intentionally left to out to preserve the scientific integrity of the study, and they will be included in the record after the study is completed.

Eligibility Criteria:
Inclusion Criteria:

* Full term: gestational age \> 37 weeks
* Exclusively breastfed (\< 2 weeks of cumulative formula exposure). Any formula consumption on a given day is considered one day of formula exposure. During the intervention, if the participant receives more than 50% of the liquid diet from infant formula, s/he will be excluded from the study.
* Maternal conditions such as gestational diabetes mellitus, preeclampsia, multiple pregnancies are acceptable.

Exclusion Criteria:

* Large for gestational age or small for gestational age
* Antibiotic use from birth to the time of enrollment
* Documented food allergies
* Previous complementary food exposure
* Conditions that would affect protein metabolism or growth
N-acetyl Cysteine in Post-reperfusion Pulmonary Injury in Chronic Thromboembolic Pulmonary Hypertension.

This study will evaluate the use of N-acetyl cysteine in post-reperfusion pulmonary injury in patients with chronic thromboembolic pulmonary hypertension undergoing pulmonary balloon angioplasty and pulmonary endarterectomy. Half of the patients will receive N-acetyl cysteine and the other placebo.

For chronic pulmonary embolism thrombus hypertension, the potentially curative treatment is endarterectomy, however in 12 to 60% it does not present surgical susceptibility, so pulmonary balloon angioplasty is the secondary option. In these procedures the complication that occurs most frequently is pulmonary oedema after reperfusion is a frequent complication (17.8-65%), appears between 24-72 hours after the intervention and the diagnosis is made in the presence of infiltrate interstitial in chest radiography or computed tomography of the chest. Initially it was believed that it was difficult due to the increase in perfusion of secondary flow in the territory due to pulmonary vascular dilation, it is now believed that microtraumatism is involved by the guides and balloon used, vascular dysfunction and cytokines and innate immunity and adaptive, complement activation, coagulation cascade activation, apoptosis pathway activation, endothelial dysfunction caused by reperfusion contribute to cell dysfunction.

The use of N-acetyl cysteine for its antioxidant properties, inflammatory response attenuator, reduction of reactive oxygen species (ROS) and that in addition to having already had to reduce the condition of decrease in post-reperfusion ischemia15,16 in other situations is a viable option in the treatment of acute post-reperfusion edema in patients sometimes a pulmonary endarterectomy and balloon pulmonary angioplasty.

Eligibility Criteria:
Inclusion Criteria:

- Patients who are diagnosed with group 4 pulmonary hypertension and are susceptible to pulmonary endarterectomy or balloon angioplasty in patients over 18 years.

Exclusion Criteria:

* Patients who do not accept admission to the trial.
* Presence of arterial hypotension or sepsis.
Horse Assisted Rehabilitation Postoncologic Treatment in Children and Adolescents: Physical and Psychological Effects

Clinical trial on the physical and psychological effects of Horse Assisted Rehabilitation after the treatment of cancer in children 4 to 18 years of age.

Randomized controlled open labelled trial. Duration: 6 months. Groups: Control Group (standard follow-up) and Intervention Group (one weekly rehabilitation session assisted by horse). Participants: 30 children, 4 to 18 years of age, after 6 months of the discharge of the cancer treatment with nervous system involvement.

Eligibility Criteria:
Inclusion Criteria:

* Children between 4 and 18 years of age, who had suffered a cancer with affectation of the Central Nervous System
* With or without motor, functional and / or cognitive deficits or neurological disorders due to their basic problem or be as a consequence of the therapeutic procedures, with any degree of disability
* More than 6 months after receiving the discharge of oncology (chemotherapy or radiotherapy)

Exclusion Criteria:

* Immunodepression
* Hypotonia with severe pelvic instability that does not allow seating on the horse safely
* Weight greater than 80Kg.
* Phobia to horses
Sports-related Concussion: Physiological, Biomechanical and Cognitive Methodology

The study aims to investigate the changes in physiological, biomechanical and cognitive performance under a traumatic sport-event (i.e., rugby match).

Background: Regular participation in moderate-to-vigorous physical activity in contact sports may be related to increases in cerebrovascular injury and head trauma. The diagnosis of head injury is lacking in validated objective measures immediate post event. Diagnostic markers may also be confounded by the exercise type and intensity. Therefore, it deserves further examination on a variety of functional (biomechanical and motor control) performance and blood-based biomarkers to determine how these indicators are affected by contact sport and the incidence of head injury. The study aims to investigate the changes in physiological, biomechanical and cognitive performance under a traumatic sport-event.

Methods: The study will use a two-group randomized controlled trial (RCT) with double-blinded approach, comprising a traumatic sport-event group and a control group. Thirty rugby-7s players will be recruited and randomly assigned to one of the two groups, where the intervention group will play three consecutive rugby matches. Data will be collected pre and post rugby match performance. Particularly, demographic and anthropometric data will be collected at baseline and pre-match. Venous blood, biomechanical data, and cognitive-motor task data will be collected at baseline, pre-match, and after each of 3 consecutive matches. Notational analysis will be performed after each match. Venous blood will be collected 24, 48, and 72 hours after the 3rd match.

Discussion: It is expected to see a reduction in whole-body movement, coordination, and cognitive-motor tasks as the number of games continues through fatigue and/or traumatic events. It is also expected that changes in blood-based biomarker concentrations to correlate with changes in biomechanical and cognitive-motor tasks. The proposed study will yield meaningful, ecologically valid research regarding the occurrence of concussive events, the influence of these on the biological system of the performer, with direct impact on clinicians, scientists, and sport governing bodies. The scope of this study will have implications on health and wellbeing within sporting populations at all levels, genders, and ages. Additionally, the findings will facilitate greater understanding about the human responses to exercise induced trauma.

Eligibility Criteria:
Inclusion Criteria:

(1) Participants should be 18 years old or above; (2) no restriction of physical mobility; (3) no uncontrollable mental disorders; and (4) professional rugby-7s player.

Exclusion Criteria:

(1) less than 18 years old; (2) have restriction of physical mobility; (3) have uncontrollable mental disorders; and (4) training duration of rugby is less than one year.
Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes

As part of Phase II of the NIH SBIR grant, the study will conduct a randomized controlled clinical trial in which the MapHabit system (MHS) will offer a caregiver training product that is linked to MHS, an Alzheimer's disease or related dementias (AD/ADRD) assistive technology product that uses visual maps to improve a patient's behavior and sense of autonomy. MapHabit's combined areas of focus, i.e., offer a single integrated product to address the caregiver and the person under this caregiver's care, are unique and will create a new standard in the field to reduce caregiver burden in the setting of caring for individuals with AD/ADRD. Additionally, the study will integrate enhanced user support modules, i.e., gamifying, dashboarding, and social networking, to improve the Caregiver Training Program (CTP) experience.The study will be a randomized controlled clinical trial, in which two conditions will be investigated: 1) control condition in which the MHS alone is incorporated in the participant's daily care and 2) experimental condition in which the MHS+CTP is implemented into the daily care received by participants. The sample size will be a total of 50 patient-caregiver dyads, 25 in each condition. The study duration will be a 6-month intervention.


Eligibility Criteria:
Inclusion Criteria:

* Individual diagnosed with Alzheimer's disease or other related dementia (ADRD) in their mild to moderate stage of impairment
* Participating caregiver of individual with dementia must be the primary caregiver
* Proficient in English

Exclusion Criteria:

* Individual not diagnosed with ADRD
* Participating caregiver of individual with dementia is NOT the primary caregiver
* Not proficient in English
Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis

The exact efficacy of Zuoqing SAN enema in the treatment of Ulcerative colitis (UC) has been clinically verified. In this study, Zuoqing SAN was used to treat UC patients with large intestine damp-heat syndrome, and the traditional chinese medicine (TCM) syndrome type was large intestine damp-heat syndrome. The changes of symptoms and signs of patients before and after treatment were observed and compared, and the clinical efficacy of Zuoqing SAN in the treatment of UC large intestine damp-heat syndrome was evaluated by combining the changes of patients' symptoms, related blood indicators, improved Mayo total score, overall syndrome efficacy, clinical comprehensive efficacy and other aspects. By replicating the rat UC model, the effects of Zuoqing SAN on general survival state, colonic gross appearance and histopathological changes, related inflammatory factors, peroxisome proliferator-activated receptor γ (PPAR-γ) /nuclear factor kappa-B（NF-κB) /signal transducerand activator of transcription 1 (STAT1) pathway, macrophage M1, M2 phenotype and microangiogenesis were observed in UC rats. Thus, the specific mechanism of Zuoqing SAN in the treatment of UC was revealed. In this study, the therapeutic effect of Zuoqing Powder on UC was investigated through clinical and animal experiments, and the specific mechanism of action was studied.


Eligibility Criteria:
Inclusion Criteria:① Clinically diagnosed UC; ② The severity of UC is mild to moderate.

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Exclusion Criteria:① The severity of UC is severe; ②patient with Severe liver, kidney, heart and brain diseases; ③ Patients with Chinese medicine allergy; ④ Pregnant or lactation patients.

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Cardiovascular Function in Sub Maximal Exercise and Performance in Three Daily Activity Tests After Stroke

The purpose of this study is to explore the relationship between cardiovascular function of persons with post stroke conditions and their performance in three field tests. This is a validation study, aiming to determine during which of two activities VO2 measurements better express the functional restrictions caused by stroke, And to find out whether the Total Heart Beat Index can be used in the case of stroke survivors for the prediction of mechanical efficiency when measured during stair-climbing and of energy cost during treadmill walking.

The hypothesis is that Stair Climbing (STC) is a more suitable form of exercise capacity testing compared to Treadmill Walk (TMW) since it potentially requires a greater amount of external work, and therefore will show stronger correlation with functional tests demonstrating the same ability, whereas TMW does not utilize the movement capability of participants to the fullest.

Another hypothesis is that cardiac response to the exertion can be used as a predictor of those measures during these exertions in the post stroke population.


Eligibility Criteria:
Inclusion Criteria:

* Having acquired stroke at least 1 year before testing
* Chronic weakness and/or spasticity of the affected side
* Independent stair-climbers (with hand-rail)
* Received medical clearance from a physician
* With cognitive level sufficient to comprehend instructions
* Participants' age will range between 40-69
* Use of walking aid is permitted as long as the participant is able to walk on a treadmill with hand-rail.

Exclusion Criteria:

* Unable to understand instructions
* Unable to ambulate
* Severe aphasia
* Heart failure or other medical conditions that preclude participation in the study.
Eucapnic pH Compared With Arterial pH and Base Deficit

Neonatal asphyxia per partum can be complicated by severe neurologic sequelae and can lead to neonatal death. Of the 0.2% of live births to cerebral palsy, 10 to 28% would be secondary to neonatal acidosis. Only metabolic acidosis plays a neurotoxic role, explaining the recent interest of Racinet et al. in the development of a new biochemical marker, more specific than pH or base deficit, of neonatal asphyxia per partum at risk of anoxo-ischemic encephalopathy. This eucapnic neonatal pH raises the hope of a biochemical marker of situations at risk of poor prognosis, with high diagnostic value, prognostic and forensic.

Our hypothesis is that eucapnic pH is more efficient than cord blood arterial pH and base deficit in the prediction of adverse neurologic outcomes.


Eligibility Criteria:
Inclusion Criteria:

* All birth more than 37 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant
* from 1st of january 2000 to 31 december 2016

Exclusion Criteria:

* Infants born out of the hospital and secondarily hospitalized in the hospital Femme-Mère-Enfant
* Children with congenital anomalies or without valid arterial and venous umbilical cord samples
A Multicenter, Randomized, Double-blind Non-inferiority Trial to Evaluate the Efficacy and Safety of Entelon®

This was a multicentre, randomised, double-blind controlled study that compared the efficacy and safety of V. vinifera extract, calcium dobesilate (CD), and placebo in subjects with DME. Patients made 6 clinic visits, namely the screening visit; baseline visit (T0); and follow-up visits at 3 (T3), 6 (T6), 9 (T9), and 12 (T12) months.

Eligible patients were randomised to one of the three study groups in a 1:2:2 ratio (placebo:GSPE:CD group). The randomization schedule was generated and prepared using cubeIWRS® solution (CRScube Inc., Seoul, South Korea, HQ). Randomization was performed using a complete randomization algorithm according to the order of the baseline visit. Subjects took three tablets of a masked study medication three times daily for 12 months; the first dose was taken in the morning of the baseline visit (T0) after baseline assessments were performed, and the last dose was taken in the evening before the month 12 visit (T12). Three daily oral doses of 50mg tablets of GSPE (Entelon®, Hanlim Pharm, Seoul, South Korea) were administered to patients in the GSPE group. Placebo tablets lacked GSPE, but their appearance was identical to that of the study group tablets. Commercially available 250mg CD tablets (Doxium®, Ilsung Pharm, Seoul, South Korea) were used in this study. The identity of the masked study medications was concealed by storing the medications in individually sealed envelopes at the study sites.

Eligibility Criteria:
Inclusion Criteria:

* Singing a written informed consent prior to selection
* type 2 DM aged between 40 and 80 years
* Diabetes is well controlled with drugs for at least 3 months(HbA1c ≤9%)
* Best-corrected visual acuity over 0.5(20/40) by using ETDRS cisual acuity test
* Diabetic macular edema with hard exudates CSMT ≤300µm

Exclusion Criteria:

* Lase therapy or intravitreal injection(anti-VEGF, steroid) intraocular surgery within 6 months of enrollment
* Concomitant macular disease (such as retinal vascular occlusion, choroidal neovascularization, epiretinal membrane, etc)
* Poor image of optical coherence tomography(signal strength under 50% of narmal value)
* Concomitant therapy(Kallidinogenase, Vaccinium myrtillus extract, sulodexide)
* Non-controlled hypertension(systolic pressure \>140mmHg or diastolic pressure \<90mmHg)
* Severe renal insufficiency(creatinine \>2.2mg/dL, or undergoing dialysis)
Biomarkers of the Response to Osteopathic Manipulation

The purpose of this study is to identify non-invasive biomarkers of the physiologic response to Osteopathic Manipulative Treatment (OMT).


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults between the ages of 21 and 60

Exclusion Criteria:

* Eating or drinking anything but water or chewing gum within an hour of the appointment
* Rib fracture
* History of unstable cardiac arrhythmia or symptoms related to the chest cavity (difficulty breathing, chest pain)
* Symptoms suggestive of bowel obstruction (abdominal bloating with pain, nausea and vomiting, diarrhea)
* Pregnancy
* History of Sjogren's Syndrome