cyrilzakka/clinical-trials huggingface dataset:
What Are my Options to Stay Safe at Home: Technology For Aging at Home

Most older people want to stay at home as long as possible. Effective self-management for people losing autonomy depends on reliable monitoring of their mobility, health and safety and active implication in decision-making. New technologies have the potential to provide information about changing patterns that reflect changing care needs. This information could help older adults, caregivers and health professionals to participate in decision-making about housing options when a change in living environment needs to be considered.

This is a multi-phase study to be conducted in 3 countries: Canada (Quebec and Alberta), Sweden and Netherlands. The primary objective is to provide e-decision support technology that will facilitate self-management in the context of aging in place and foster informed value congruent decisions about options to age safely at home.

The aim of the project is to develop and validate a e-technology based on already existing components (e.g. GPS devices, diverse e-platforms and decision support interventions) to 1) help older adults with mild cognitive impairment/memory problems to stay safely at home as long as possible and 2) to provide older adults with decision support tools to help them make informed value congruent decisions (e.g. foster a shared decision-making process) regarding aging at home in a safe manner.

The secondary objectives are:

1. Assess autonomy and mobility of older adults with mild cognitive impairment/memory problems living at home.
2. Inform shared decision-making processes about options to safely age in place for all those involved.

The investigators will apply an integrated Knowledge Translation (iKT), comparative, mixed-methods approach to explore, older adults living at home with mild cognitive impairment/memory problems, their use of space in their homes and neighbourhoods.

The project is divide into 4 work package (WP). In more details, during WP1, the investigators will collect spatial data (e.g. using GPS) and self-reported data (e.g. travel diaries, walking interviews, in-depth interviews, surveys). At WP2, the investigators will use iterative end-user feedback and end-user consultation discussion group to tailor a decision support technology to knowledge-users. At WP3, investigators will assess user opinion regarding factors that could influence their use of the newly adapted e-decision support technology. Finally, at WP4 the investigators will triangulate data and take into account differences between jurisdictions.

This collaboration and our cross-country comparisons will contribute to scaling up e-decision support solutions in the future for the older adults with mild cognitive impairment/memory problems who want to age safely at home.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 65 years
* Living at home
* Diagnosed with mild cognitive impairment or experiencing memory issues
* Able to read, understand and write
* Can provide informed consent

Exclusion Criteria:

* Older adults who are not able to provide informed consent
* Living in nursing home or hospital
Comparison of Kinesiophobia, Balance, Falling and Walking Speeds of Elderly's With Physical Frailty With Alzheimer's

In this study, Kinesiophobia, Balance, Falling, Walking Speeds of Elderly People with Cognitive Frailty with Alzheimer's Dementia, Elderly with Physical Frailty and Healthy Elderly Individuals will be compared.

In this study, Kinesiophobia, Balance, Falling, Walking Speeds of Elderly People with Cognitive Frailty with Alzheimer's Dementia, Elderly with Physical Frailty and Healthy Elderly Individuals will be compared.

For research, 3 Groups will be included, including elderly individuals diagnosed with Alzheimer's Dementia, physically fragile elderly individuals and healthy elderly individuals staying at the Private Dikmen Nursing Home and the private Uluçınar Nursing Home. The research will be conducted with a total of 54 individuals who voluntarily participated in the study from June 2023 to February 2024.

The criteria for participation in the study of elderly individuals diagnosed with 1st group Alzheimer's Dementia are to be over 65 years old, to be able to walk independently and to be diagnosed with early or middle stage Alzheimer's by a doctor.

The criteria for participation in the study of physically frail elderly individuals for 2nd group is to be over 65 years old, to be able to walk independently and appearing fragile or pre-frail according to the Frail Questionnaire.

The criteria for participation in the study of the 3rd group of healthy elderly individuals were to be over 65 years old, not to have any psychiatric, neurological and orthopedic problems, and to be able to walk independently.

As a data collection tool; For the descriptive characteristics of the patients, a form containing demographic information will be used. Timed Up and Go Test, Berg Balance Scale, 2 Minutes Walking Test will be used to evaluate balance and gait. Frail Questionnaire and Clinical Frailty Scale will be used for the evaluation of frailty.

Tampa Scale will be used for kinesiophobia assessment. The Fall Activity Scale (Tinetti) will be used to assess the fear of falling. In addition, the cognitive status of individuals will be evaluated with the Mini Mental State Test and the Montreal Cognitive Assessment Test.

Eligibility Criteria:
Inclusion Criteria:

* being over the age of 65 and being able to walk independently.
* Individuals who have been diagnosed with early or mid-stage Alzheimer's by a physician.
* Appearing fragile or pre-frail according to the Frail Questionnaire.

Exclusion Criteria:

* Who has an obstacle to doing physical activity.
* Those who have undergone an operation in the last 6 months.
* Those who do not agree to participate in the research.
* Those who have been diagnosed with late-stage Alzheimer's dementia.
Respiratory Muscle Strength in Patients With NMD

The purpose of this study is to determine if inspiratory muscle strength training (IMST) will impact maximal inspiratory pressure and pulmonary function in patients with neuromuscular disease.

Subjects undergo a 12-week period of inspiratory muscle strength training. Respiratory strength is assessed before and after the training period.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of neuromuscular disease
* Clinical evidence of impaired pulmonary function

Exclusion Criteria:

* Above or below age range
* No clinical evidence of impaired pulmonary function
* No diagnosis of a neuromusuclar disease
* Presence of an acute illness at time of study
* Participating in other research studies involving investigational drugs
* Diagnosis of a primary pulmonary disease
* Use of tobacco products
Corneal Confocal Microscopy in Patients With Type 1 Diabetes

Assessing the use of corneal confocal microscopy to evaluate for early neuropathy changes in subjects with Type 1 Diabetes.

Rationale: Poorly controlled diabetes mellitus is associated with microvascular complications, which includes peripheral neuropathy. Peripheral neuropathy associated with diabetes is a painful condition. Its diagnosis is hampered by painful and long nerve conduction studies which fail to diagnose small nerve neuropathy. It is important to study methods of noninvasive methods of early detection, which are sensitive and specific in diagnosing early neuropathy and we propose a novel study that this can be detected in the cornea of the eye.

Aims:

* Estimate corneal small nerve fiber damage in young T1DM subjects (corneal fiber density, nerve branch density, and fiber length) and compare the results to healthy controls using corneal confocal microscopy (CCM).
* Estimate corneal nerve fiber damage in subjects with diabetes, with peripheral neuropathy and subjects with diabetes without peripheral neuropathy, diagnosed by skin biopsies and nerve conduction studies
* Obtain much needed normative values for CCM in adolescents and intraepidermal nerve fiber density from skin biopsies in subjects with type 1 diabetes.
* As a secondary outcome measure, to compare serum biomarkers including leptin, TNF alpha, and fibrinogen in patients with diabetes in those with neuropathy Vs. without neuropathy.

Eligibility Criteria:
Inclusion:

* Subjects with diabetes:
* 18-30 years (cohort 1), adolescents ages 13-17 years (cohort 2).
* Type 1 Diabetes diagnosed via standard ADA criteria

Matched Controls:

* Match for age and gender
* Hemoglobin A1c \<6.5%

Exclusion:

For all subjects:

* Contact lens wearers
* Diseases that could damage the cornea, other than diabetes.
* Neurologic disease
* Psychiatric disease
* Amputation
* Foot ulcers
* Pain not of neuropathic origin.
* Presence of Lupus, Sjogren's syndrome and Celiac disease
* Hyperlipidemia requiring lipid-lowering medications
* Peripheral vascular disease
* Neuropathy due to anything besides diabetes
* Presence of any medical condition that may affect nerve conduction (e.g., radiculopathy).

For healthy controls

* Family history of Type 1 Diabetes
Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19

The overall objective of this project is to develop an emergent treatment protocol using adoptive T-cell therapy for the treatment of severe COVID-19. The central hypothesis is that SARS-CoV-2 specific T cells from convalescent donors who have recovered from COVID-19 can be manufactured expeditiously for the treatment of severe SARS-CoV-2 infections.

A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of Coronavirus Disease 2019 (COVID-19). Currently, no vaccine or specific treatment has been proven to be effective. While waiting for vaccine to be developed, passive immunity can be acquired immediately by adoptive transfer of SARS-CoV-2 specific T cells from convalescent donors into newly infected patients.

The aim of this protocol is to demonstrate the feasibility of preparing SARS-CoV-2 specific T cells from convalescent donors for urgent clinical use. The specific hypothesis is that SARS-CoV-2 specific T cells can be isolated from the blood of convalescent donors rapidly and efficiently using SARS-CoV-2 specific peptides and an automated medical device for emergent treatment of severe COVID-19 disease.

A minimum of 8 convalescent donors will be recruited from Singapore to attain HLA sharing with at least 90% of the general population.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 to 65
* Had a history of COVID-19 with documented positive test for SARS-CoV-2 in the past
* Has recovered from COVID-19 and is now suitable for blood donation, fulfilling all standard blood donor criteria
* Negative test for SARS-CoV-2 currently

Exclusion Criteria:

* Do not meet the standard criteria for blood cell donation at National University Hospital or Singapore General Hospital.
Decreasing Patient Dissatisfaction With Unplanned Cesarean Sections

Patient satisfaction after an unplanned cesarean section was studied and in the previous study it was noted that there were common themes that lead to patient dissatisfaction. The four common themes were: lack of trust regarding the indications for surgery, communication issues, loss of control, and fear during the situation. The purpose of this second phase of this study is to try and improve patient dissatisfaction by offering additional emotional support prior to the c/s with the hope of decreasing the trust issues toward physicians, decreasing the communication barriers, and decreasing the fear and loss of control. The additional emotional support that will be received prior to the cesarean section will be scripted based upon the findings of the investigators' prior study - the patient will be asked four questions and each question addresses the four themes that were noted in the previous study.

All patients admitted to the Labor and Delivery unit at Albany Medical College who are in labor or being evaluated for possible indicated delivery will receive information regarding the study. Those who consent to participation, if they are then determined to need a cesarean birth will be randomized into two groups. The first group will receive pre-operative counseling by the obstetrics resident who will be performing the cesarean, the second group will receive usual care. The counseling sheet was determined based upon the findings of a previous study done at this institution, and addresses four themes that were recurrent aspects of patient dissatisfaction after cesarean birth: poor communication, trust of physicians, loss of control, and fear of surgery.

Two weeks after the cesarean section, patients participating in the study are called on the phone by one of the investigators. A patient satisfaction survey, using a Likert scale is administered. This investigator is blinded as to whether the patient has received the additional counseling or not. Comparison of these scores will be used to determine whether pre-operative counseling can reduce dissatisfaction in patients undergoing unplanned cesarean sections.

Eligibility Criteria:
Inclusion Criteria:

* pregnant patient admitted at Albany Medical Center
* Faculty group patient

Exclusion Criteria:

--Patients who have scheduled cesarean sections
Assessment of Endometrial Receptivity in Recipients of Donated Oocytes

The purpose of this study is to determine whether endometrial receptivity markers obtained by endometrial sampling are effective in prediction of in vivo human embryo implantation.

Since the introduction of In vitro fertilization (IVF), substantial improvements have been developed in ovulation induction, oocyte retrieval, fertilization capability and embryonic development. However, the end point which is to improve implantation and pregnancy rates after transferring embryos, remains below physiological expectations. It has been estimated that clinical implantation in the human is efficient in no more than 30% of cases considering that only one embryo is present in natural cycles, which gives us a 30% implantation rate.

A frequent pitfall found in the literature is the consideration that implantation is the result of good embryonic quality. Although this is completely true, it is not the only truth because the maternal endometrium is at least of equal relevance. In ovum donation, the endometrial factor could also be improved by individualizing the implantation window in each patient. In this proposed research we will analyze suggested markers of endometrial receptivity in order to optimize human implantation in patients undergoing assisted reproductive technologies focusing on improving endometrial receptivity in IVF and ovum donation patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for IVF or OD

Exclusion Criteria:

* Cervical stenosis
Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients

This study aims to explore the effects of tacrolimus sustained-release capsules on the incidence of biopsy-proven acute rejection(BPAR) and fibrosis in pediatric liver transplant recipients.

Tacrolimus is a commonly used immunosuppressant after liver transplantation. However, with increased postoperative time and a decline in postoperative compliance, some children may miss medication, leading to acute rejection. Repeated rejection can cause fibrosis of the transplanted liver, seriously impacting graft function and even postoperative survival, sometimes resulting in the need for a second liver transplant. In adult liver transplant recipients, tacrolimus sustained-release capsules have been shown to significantly improve overall and transplanted liver survival compared to conventional formulations (immediate-release tacrolimus，taken twice daily). Therefore, this study aims to explore the effects of tacrolimus sustained-release capsules on the incidence of biopsy-proven acute rejection(BPAR) and fibrosis in pediatric liver transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

1. Children (≤18 years old) who have undergone liver transplantation, with no gender limitations;
2. Able to completely swallow capsules;
3. Have been using immediate-release tacrolimus for at least three months prior to study enrollment;
4. Have normal blood count, liver and kidney function, coagulation function, and considered clinically stable by researchers;
5. Undergo a programmed liver biopsy;

Exclusion Criteria:

1. Multi-organ combined transplantation or multiple liver transplantation;
2. Adjuvant liver transplantation or use of bioartificial liver therapy;
3. ABO incompatible children with liver transplantation;
4. Allergic to tacrolimus;
5. Participation in any other clinical study within 3 months prior to enrollment;
6. Use of tacrolimus sustained release capsules before enrollment;
7. Tacrolimus trough concentration lower than 3.5 ng/ml at the time of screening;
Treatment of Influenza and ARVI in Children by Kagocel ®

This study examined the etiology of acute respiratory viral infections (ARVI) during the 2015-2016 season, evaluated the statistics of the incidence of influenza and ARVI in this period (epidemiology: severity of the disease and bacterial exacerbations; demographics of patients; duration and timing of treatment; safety; quality of treatment), and evaluated the effectiveness of complex therapy with an emphasis on the using of interferon inducers in hospitalized children aged 3 to 11 years.

This non-interventional observational study included 80 patients aged 3 to 11 years who were hospitalized with influenza and acute respiratory viral infections (ARVI) symptoms at any time from the onset of the disease (up to 15 days) and who were prescribed the interferon inducer Kagocel as an antiviral medicine.

The diagnosis of influenza and ARVI was confirmed in accordance with the world health organization (who) guidelines for the pharmacological treatment of pandemic influenza A (H1N1) 2009 and other influenza viruses.

All patient examinations are conducted in accordance with local routine clinical practice and local and international standards of care.

After the end of treatment, the following data were collected and analyzed:

* demography
* disease severity
* anamnesis data (data of influenza vaccination in the current season; pre-school facilities visits; previous contacts with a patient with influenza / ARVI; previous antiviral therapy for the current episode of the disease; concomitant diseases)
* body temperature (morning/evening)
* chills and fever (cumulative score based on all symptoms: 0-no symptoms, 1-mild, 2-moderate, 3-severe)
* intoxication symptom (cumulative score based on all symptoms: 0-no symptoms, 1-mild, 2-moderate, 3-severe)
* catarrhal symptoms (cumulative score based on all symptoms: 0 - no symptoms, 1-mild, 2-moderate, 3-severe)
* timelines: the beginning of the disease, the first visit to the doctor, the beginning of treatment, the duration of the disease
* determination the causative agent by PCR (on presentation of patients and their discharge on 5-6 days from start of therapy)
* antiviral therapy (Kagocel dose depending on age)
* symptomatic treatment of the current episode of influenza or ARVI before and during the patient's hospitalization
* bacterial exacerbations (Yes/no)
* treatment of bacterial exacerbations (drug name)
* adverse events

Eligibility Criteria:
Inclusion Criteria:

1. The patient's age from 3 to 11 years inclusive.
2. The patient was hospitalized with symptoms of influenza and ARVI.
3. The appointment of drug Kagocel ® as an antiviral therapy of influenza or ARVI by the doctor during hospitalization
4. No history of allergy and / or hypersensitivity to the components of the drug Kagocel ® .
5. Signed informed consent to participate in the study.

Exclusion Criteria:

- patients who received antiviral and immunomodulatory medications within 15 days prior to hospitalization
Ultrashape System in Combination With VelaShape II Device for Circumferential Reduction

The purpose of this study is to compare the clinical performance of the Ultrashape system with VelaShape II device for reduction of the waist.

UltraShape® Contour I V3 system is a non-invasive (not breaking the skin) focused ultrasound for body contouring purposesdesigned to selectively disrupt sub-dermal fat cells employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves, remain intact. There are no thermal effects. Fat-cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.

VelaShape is a non-invasive device for Body Reshaping and Cellulite Treatment. VelaShape combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation.

Eligibility Criteria:
Inclusion Criteria:

1. Fat thickness of at least 1.5 cm in the anterior abdominal and flanks prior to initial treatment (measurement by caliper)
2. For women of child-bearing potential: negative pregnancy test in the 24 hour period prior to enrollment and 24 hour period prior to each treatment or FU visit (measured in urine)
3. General good health confirmed by medical history and skin examination of the treated area
4. Written informed consent to participate in the study
5. Ability to comply with the requirements of the study
6. BMI≤ 30

Exclusion Criteria:

1. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
2. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy
3. Previous liposuction in the treatment areas
4. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
5. Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment area
6. Poor skin quality (i.e., laxity)
7. Abdominal wall diastasis or hernia on physical examination
8. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
9. Obesity (BMI \> 30)
10. Childbirth within the last 12 months or women who suckling a child
11. Any acute or chronic condition which, in the opinion of the Investigator, could interfere with the conduct of the study
12. Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months)
13. Inability to comply with circumference measurement procedure (e.g., inability to held breath for the required duration)
14. Participation in another clinical study
15. Previous body contouring treatments in the treatment areas