cyrilzakka/clinical-trials huggingface dataset:
A Randomized Trial of Electronic Integration of Care for Better Diabetes Outcomes; The COMPETE II Study

This study will evaluate whether the use of an electronic diabetes tracker by both patients and family physicians in Ontario improves diabetes outcomes, satisfaction with care and with technology and health data privacy issues. As part of the study, the investigators will be able to test whether practices that use computers perform any better than practices using paper. The investigators also will be developing the first Canadian computerized chart summary for each patient that can be communicated securely in emergencies (the Emergency Health Record) and read by all current electronic systems.


Eligibility Criteria:
Inclusion Criteria:

* Adult, cognitively intact, consenting people with diabetes within enrolled practices

Exclusion Criteria:

* Non-english speaking
* Cognitively impaired
A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder

The primary objective of this study is to assess the efficacy of 2 doses of centanafadine sustained-release (SR) (200 milligrams \[mg\] and 400 mg total daily dose \[TDD\]) compared with placebo in adults with moderate to severe binge eating disorder (BED).


Eligibility Criteria:
Inclusion Criteria:

* Adult participants 18 to 65 years of age (inclusive) at the time of informed consent.
* A primary diagnosis of BED, or is diagnosed at screening, according to Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and confirmed by the Structured Clinical Interview for DSM-5 (SCID).
* BED with a history of at least moderate severity.
* A rating of 4 or higher on the Clinical Global Impression - Severity (CGI-S) at screening and baseline.
* Body mass index (BMI) of 18 to 45 kg/m\^2, inclusive.

Exclusion Criteria:

* Lifetime history of bulimia nervosa or anorexia nervosa.
* Participation in a formal weight loss program within 3 months of screening or planning to start a weight loss program during the trial.
* History of bariatric surgery.
* Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 18.
BIA-Guided Dry Weight Assessment on Sleep Quality in Chronic Hemodialysis Patients

Based on many previous data proving hypervolemia in chronic hemodialysis patients could lead to sleep apnea and poor sleep quality. The investigators conduct this trial to evaluate whether more accurate dry weight assessment with BIA in these patients can lead to better sleep quality (measured by sleep actigraphy and questionnaires). The investigators will enroll 30 chronic hemodialysis patients in hemodialysis unit of Ramathibodi hospital whose age \> 18 years with subclinical hypervolemic status and baseline Pittsburgh sleep quality index (PSQI) score \> 5 into study. Patients with bed-ridden status, alteration of consciousness and unstable hemodynamics will be excluded. Then eligible patients will be randomized into 2 groups, BIA-guided and standard clinical guided dry weight assessment. The investigators will assess participants' dry weight at beginning of study, 3rd month and 6th month. Sleep actigraphy parameters (eg. total sleep time, sleep efficiency), sleep questionnaires score, left ventricular mass index by echocardiography, ambulatory blood pressure monitoring and blood chemistry results were collected at beginning of study, the end of 1st, 3rd and 6th month. The primary outcome is change of sleep actigraphy parameters between the groups. The secondary outcomes are change of sleep questionnaires scores, change of left ventricular mass index, change of ambulatory BP monitoring and also cardiovascular complications between groups.

This randomized control trial aim to detect the better volume control guided by bioimpedance may improve ambulatory blood pressure control, sleep quality and left ventricular hypertrophy.

Eligibility Criteria:
Inclusion Criteria:

* regular hemodialysis 3 times/week
* PSQI score \>5
* Subclinical hypervolemia

Exclusion Criteria:

* bed ridden status
* alteration of consciousness
* unstable hemodynamics
The Effect of Information and Coping With Anxiety Training Given to Women Before Hysterectomy on Their Level of Anxiety

Purpose: In this study, it was aimed to determine the effect of information and coping with anxiety training given to women before they undergo hysterectomy on their anxiety levels.

Design and Methods: The parallel group post-test randomized controlled experimental design was used in the study. The study sample comprised 59 women.


Eligibility Criteria:
Inclusion Criteria:

* agreeing to participate in the study,
* being able to speak and understand Turkish,
* being in the age group of 18-65 years,
* being admitted to the aforementioned clinic with a planned hysterectomy surgery,
* not having any health problems preventing the person from hearing and speaking,
* being conscious, being oriented and cooperated,
* not having received any training on hysterectomy before the surgery and during discharge.

Exclusion Criteria:

* not agreeing to participate in the study,
* not being able to speak and understand Turkish,
* being under the age group of 18 years,
* not being admitted to the aforementioned clinic with a planned hysterectomy surgery,
* having any health problems preventing the person from hearing and speaking,
* not being conscious, being oriented and cooperated,
* having received any training on hysterectomy before the surgery and during discharge.
Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome

This present study is specifically designed to examine the efficacy and safety of a high pre-treatment dose of atorvastatin in Asian patients with NSTE-ACS in China and the Republic of Korea, by using a treatment paradigm similar to that employed in the ARMYDA-ACS study.


Eligibility Criteria:
Inclusion Criteria:

* Non-ST elevated ACS; LDL-C \> 80 mg/dl

Exclusion Criteria:

* ST elevated acute myocardial infarction; previously or currently treated with atorvastatin or other statins
Early Brain Damage Assessment in Aneurysmal Subarachnoid Haemorrhage in Predicting Cognitive Impairment

the goal of this type of study : observation study is to learn about cerebral edema and hematoma in aneurysmal subarachnoid hemorrhage the main questions it aims to answer are current clinical practices lack predictive models to identify early structural brain abnormalities affecting cognition.

the development of a predictive model termed the a-SAH Early Brain Edema/Hematoma Compression Neural (Structural Brain) Networks Score System (SEBE-HCNNSS).

Eligibility Criteria:
Inclusion Criteria: first-ever stroke, diagnosed with SAH via CT scan within 24 - 48 hours or lumbar puncture; 2) age between 18 and 70 years; 3) Confirmation of cerebral aneurysm by digital subtraction angiography (DSA) and/or CT angiography (CTA); 4) absence of neurological or psychiatric disease history and each unruptured intracranial aneurysm patient must be admitted to the hospital in excellent preoperative and pre-interventional condition; 5) Informed consent is signed by the patient and/or family. 6)Clinical diagnosis of Alzheimer's Disease Must be able to swallow tablets.

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Exclusion Criteria: 1) patients over 70 years old; 2) presence of neurological focal deficits or severe aphasia; 3) cognitive dysfunction or history of cognitive decline including craniotomy, antipsychotics, neurodegenerative diseases, and chronic subdural hematoma; 4) concurrent acute or chronic infections, corneal or pupillary abnormalities, severe autoimmune or systemic diseases such as rheumatic illnesses of the musculoskeletal system; 5) concurrent severe organic dysfunction; 6) patients with recurrent aneurysms or aneurysms not first diagnosed in our hospital; 7) diagnosis of major psychosis according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition criteria 8)Insulin dependent diabetes,9)Thyroid disease
BCC Excision Revisited

To readdress basal cell carcinoma (BCC) in the periocular region to prove histologically controlled surgical treatment efficacy and to identify high-risk characteristics.


Eligibility Criteria:
Inclusion criteria:

* Patient records were reviewed for the presence of BCC and surgical excision with frozen sections control of the wound margins in the periocular region,
* conducted between 01.01.2009 and 31.12.2019.
* Periocular was defined as the area involving the medial and lateral canthus as well as the upper and lower eyelids.

Exclusion criteria:

* BCCs outside of this region were excluded from this analysis,
* as well as incomplete records.
Physical Activity in Persons Newly Diagnosed With Multiple Sclerosis

This single group pre-post pilot intervention will examine the feasibility and initial effect of a 12-week behavioral intervention, based on the Behavior Change Wheel and Capability-Opportunity-Motivation-Behavior (COM-B) model and remotely delivered through electronic newsletters and online one-on-one video conferencing, for promoting physical activity and secondarily reducing fatigue and quality of life in persons newly diagnosed with MS (diagnosed with MS within the past 2 years). The investigators hypothesize the proposed 12-week intervention will be feasible based on process, resource, management, and scientific outcomes. The investigators further hypothesize that individuals who receive the 12-week intervention will demonstrate an increase in physical activity behavior, particularly daily step counts, and reduce fatigue.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Diagnosed with multiple sclerosis for 2 or fewer years
* Fully ambulatory
* No relapse within the last 30 days
* Non-active (Godin Leisure-Time Exercise Questionnaire - Health Contribution Score \< 14)
* Able to read 14-point font size
* Internet \& video conferencing access
* Undergoing disease-modifying therapy

Exclusion Criteria:

* Pregnancy
* Moderate or high risk for undertaking physical activity (≥ 2 affirmatives on the Physical Activity Readiness Questionnaire)
Role of Herbal Based Mouthwashes in Plaque Control

Herbal medicine has been used for thousands of years. Traditional herbal medicine is used by an estimated 80% of the world's population for primary health care. Herbal treatments have gained popularity as a dietary supplement for illness prevention and as an alternative/complementary therapy in recent years. Herbal remedies come in a wide variety of forms and can be found on the market all over the world.

Herbal mouthwashes have been increasingly popular over time. Ethnomedicines are the term used to describe them. Various substances have been tested, with phytopharmacological analyses yielding contradictory results. Many previous studies had tested the antiplaque efficiency of one herbal mouthwash with contradicting results, other studies have tested the Antiplaque efficiency of chlorhexidine, tea tree oil and Miswak, some studies had given positive outcomes and benefits of Miswak on the gingiva and others when comparing between the efficacy of Miswak over chlorhexidine mouth wash in dental practice provided results favouring both these mouthwashes.

In our proposed study we will compare the antiplaque efficiency of three herbal kinds of mouthwash, Miswak, tea tree oil and Resveratrol mouthwash. Plaque and gingival bleeding scores will be taken before the study from 6 different teeth and retaken after 2 weeks and four weeks respectively the use of the mouthwash. This study is single-blinded. Antiplaque and gingival bleeding scores from the three mouthwashes will be recorded over a period of a month and statistical analysis will be performed

Eligibility Criteria:
Inclusion Criteria:

* Patients who are medically fit
* Patients with gingival inflammation not progressed into periodontitis (AAP classification
* Patients between the age of 18-60 years

Exclusion Criteria:

* Patients who are medically compromised
* Patient who have undergone a periodontal therapy for the past 3 months
* Patients who are healthy but have been using herbal mouthwashes
Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer

The primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate will reduce serum testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma.

The primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate administered once every 26 weeks for 1 year, will lower testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma. This study will also evaluate the pharmacokinetic profile of the 45 mg formulation and assess the safety of this formulation.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of prostate cancer
* Need for androgen deprivation treatment for 1 year
* Serum testosterone level ≥ 150 ng/dL
* Life expectancy of at least 18 months
* ECOG Performance status grades 0,1 or 2

Exclusion Criteria:

* Hypersensitivity to leuprolide acetate or polylactic acid
* History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
* History of hypogonadism
Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke

Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.Stem cell transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy and safy of the transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.

Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.It will brought heavy burden to patients themselves,their family and society.Drugs,rehabilitation excise and hyperbaric oxygen will improve functions after acute stroke.However,in the chronic ischemic stroke,there was few methods to improve the functions.In recently research,stem cell will be a new methods to improve the neural function after through differentiate to nervous cells and secrete some neurotrophic factors to repair the damage. In this study, the investigators will assess the safety and feasibility of intracerebral transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic ischemic stroke. The neurological outcome will be determined after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-80 chronic ischemia stroke or patients
* With stroke history of more than 6 months, less than 60 months
* NIHSS (NIH stroke scale) score of 7 or more points
* Internal carotid artery territory infarction measured by MRI
* Can be hospitalized and signed informed consent
* With fewer effect by traditional post-stroke treatments or rehabilitations

Exclusion Criteria:

* Lacunar infarction
* Recurrent thrombotic diseases less than 6 months
* Hemorrhage stroke,brain tumor or MRI show the occlusion is not in the middle cerebral artery territory
* Pregnant women
* Can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition
* Penicillin anaphylaxis or some other drugs allergy
* Autoimmune disease
* Inaccessibility for follow up
Long-term Effects of COVID-19

The purpose of this study is to measure, monitor, and analyze long term effects of SARS-CoV-2. The main purpose is to assess the post-hospitalization outcomes of patients who were diagnosed with SAR-CoV-2 by comparing to patients who were hospitalized with an acute neurological disease.


Eligibility Criteria:
Inclusion Criteria:

* Control Participants: Males and females over the age of 18 years hospitalized and receiving intensive care for diagnosis's other than COVID-19 or an acute neurological disease and who were not diagnosed (clinically or with PCR testing) with COVID-19.
* Case Participants: Males and females over the age of 18 years who had been hospitalized at Mayo Clinic Hospital for treatment of COVID-19 confirmed by PCR test.
* We acknowledge that some participants may be unable to consent due to underlying medical conditions; an eligible proxy may provide the informed consent and provide a signature on the designated line.
* Women of childbearing age, between the ages of 18 to 55, must complete a negative pregnancy test.
* Minority individuals over the age of 18 years will be eligible to enroll.

Exclusion Criteria:

* Males and females, under the age of 18 years.
* Participants with PET/MRI non-compatible devices.
* Claustrophobia.
* Allergies to study related procedures.
* Pregnant , incarcerated, or institutionalized subjects will not be included in the study.
Sonography-Guided Volumetric Rejuvenation on Dorsal Hands

The goal of this randomized controlled study is to guide volumetric rejuvenation on dorsal hands with the maximal aesthetic appearance. The main questions it aims to answer are:

* Which fatty layer(s) is/are the most suitable for filler injection?
* Is it feasible to make precise filler injections with sonography guidance? Participants will receive sonography-guided injection on the one hand and another with blinded injection.

In our previous study, volumetric fat loss was noted in the 3 fatty laminae of dorsal hands during aging; the dorsal intermediate lamina (DIL) showed the greatest progressive fat loss after the age of 30. Volumetric rejuvenation of the 3 laminae may result in the most aesthetic appearance, especially in women. It is necessary to develop precise rejuvenation therapies according to the aging process of the dorsum of the hands that will yield the most aesthetic appearance.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of aging changes on the dorsal hands
* Aged ≥18 years

Exclusion Criteria:

* History of severe hand dermatitis
* History of rheumatic arthritis
* History of major hand trauma
* History of limb edema
* History of recent significant weight changes
* History of previous filler injection to the dorsal hands
* History of intravenous catheter insertion and hemodialysis via the forearms or hands
Effectiveness and Safety of Gordian Surgical's TroClose1200™

The use of the TroClose1200™ will be done in at least one 12mm planned access port per the TroClose1200™ Instruction for Use. The procedure will be performed routinely. Adverse Events and device malfunctions, if any, will be recorded. Subjects will be hospitalized in accordance with the hospital guidance. All subjects will be followed at 2 weeks (+/- 4 days), at 6 weeks (+/- 1 week), at 12 months (+/- 1 month) and at 24 months (+/- 2 months) in which healing, signs of hernia and adverse events will be recorded. In the 12 and 24 months visit, the hernia signs will be evaluated by ultrasound.

Subjects that sign the Informed Consent Form will be evaluated for eligible for the study per eligibility criteria. Subject medical background and underlying disease requiring intervention will be taken at screening. Procedure will be scheduled. Subjects that will eventually, for any reason, will not be operated with the TroClose1200™, will be considered as "screen failures". The use of the TroClose1200™ will be done in at least one 12mm planned access port per the TroClose1200™ Instruction for Use. The procedure will be performed routinely. Duration of use of the TroClose1200™ each time it is used will be measured, as well as the entire procedure duration, and the type of procedure. Adverse Events and device malfunctions, if any, will be recorded. The video seen in the monitors during the procedure will be kept as source data for any further analysis. The location of the TroClose1200™ used, as well as the other trocars used location, will be drawn on a special chart. Subjects will be hospitalized in accordance with the hospital guidance. All subjects will be followed at 2 weeks (+/- 4 days), at 6 weeks (+/- 1 week), at 12 months (+/- 1 month) and at 24 months (+/- 2 months) in which healing, signs of hernia and adverse events will be recorded. In the 12 and 24 months visit, the hernia signs will be evaluated by ultrasound.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years old and less than 65 years.
2. Subject is a candidate for laparoscopic surgery with at least one 12 mm trocar is to be used apart from the endoscopic access port.
3. Subject is capable and willing to comply with, and be present at, the follow-up clinic visits of the 6 weeks visit.
4. Subject is able and willing to sign a written informed consent form.

Exclusion Criteria:

1. Patients presenting factors that affect the scarring process, such as malnutrition (serum proteins \<5 g/dl or Albumin below 3 g/dl).
2. Advanced cancer.
3. Perioperative hemodynamic instability
Insulin Sensitivity of the Human CNS System: fMRI Study With Intranasal Insulin Application

The purpose of the study is to investigate whether insulin sensitivity and insulin resistance of the human brain is comparable in all insulin sensitive parts of the brain and whether correlates to other phenotypic information (i.e. whole body insulin sensitivity, BMI, age) of the study participants.


Eligibility Criteria:
Inclusion Criteria:

* Normal routine blood works
* for women: negative pregnancy test
* healthy

Exclusion Criteria:

* Type 2 diabetes
* pregnancy
* acute or chronic diseases
* Pacemakers
* Artificial heart valves
* Metal prostheses
* Implanted magnetic metal parts (screws, ...)
* Metal fragments
* Braces
* insulin pumps
* Tattoos
* claustrophobia
* reduced temperature sensation and / or increased sensitivity to warming of the body
* Ear disease or an increased sensitivity to loud noises
Evaluation of BAV in Different Hemodynamic Entities of Severe AS

The purpose of this retrospective, observational study is to compare the profit of BAV and TAVI in different subtypes of serve aortic stenosis.

The Balloon Aortic Valvuloplasty (BAV) is a catheter-based intervention, which can be used for dilatation of serve aortic stenosis. With this minimally invasive intervention an increase of the aortic valve area (AVA) and cardiac ejection fraction (EF), decrease of transvalvular gradients and ultimately a symptom relief should be achieved. The required effect is temporary and a definitive treatment should be aspired in suitable patients. Therefor Transcatheter Aortic Valve Replacement (TAVR) is available.

Following the guidelines of the European Society of Cardiology for the management of valvular heart disease from 2017, the aortic stenosis can be divided into different subtypes by using haemodynamic parameters: High-gradient AS (HG-AS), Low-Flow-Low-Gradient AS (LFLG-AS) and paradoxical Low-Flow-Low-Gradient (pLFLG-AS). Patients with LFLG-AS are suspected to have a poorer prognosis when treated curative as well as when treated palliative medicamentous, because these patients show coronary and myocardial restrictions more frequently in addition to the valvular disease.

The aim of the study is to compare safety and effectiveness of balloon aortic valvuloplasty as a bridging therapy and transcatheter aortic valve replacement as a definitive treatment in HG-AS, LFLG-AS and pLFLG-AS patients to verify whether the subtypes of aortic stenosis profit equally from these interventions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Severe Aortic Stenosos who underwent BAV

Exclusion Criteria:

* insufficient echocardiographic parameters before BAV