cyrilzakka/clinical-trials huggingface dataset:
ESM Pilot: Mobile Phones and Psychology

The research team will investigate whether there is a relation between smartphone usage and psychological parameters using the smartphone application.

There are indications for mobile phone effects on psychological and psychological functioning. Most publications on this subject report effects on 'mobile phone addiction'. A methodological problem in these studies is the collection of data in retrospect. With the mobile phone application it is possible to prevent this type of bias. By collecting real-life data in a longitudinal design with a 2 x N=1 pilot study, it is possible to obtain an impression of the relationship between mobile phone usage and emotion/behavior efficiently.

The objective of this study is to investigate whether there is a relation between smartphone usage and psychological parameters in young adults. Taking into accordance the type of research (observational) and the present state of literature (the relationship between mobile phones and psychological effects has not been studied before using the experience sampling method (E.S.M.)) the following hypothesis are formulated. It is expected that the undesired absence of one's phone will lead to an enlarged stress level. Furthermore, it is expected that an increase of phone usage will lead to more depressive symptoms, to less concentration and to sleep disturbance. Finally, it is expected that loneliness will lead to increased phone usage.

A longitudinal pilot study, in which the participant will be asked to fill out the mobile phone application questionnaire 10 times a day at random moments on a smartphone, during a 3 months period.

The mobile phone application questionnaire contains a series of multiple choice questions about the present affect (three positive, five negative), the present context and activities (physical activity, occupation, presence of other people), physical discomfort (fatigue, concentration level, pain) and mobile phone usage (frequency, frustration when unable to use phone) since the last beep. Positive affect: cheerful, mentally fit and relaxed. Negative affect: irritated, bored, lonely, stressed and worrying. The answers will be registered using a 7-point Likert scale, ranging from 'not' to 'very'.

Participants will be invited to the research location twice for a briefing (30 minutes) and a debriefing session (30 minutes). Furthermore the participants will be asked to fill out the mobile phone application questionnaire on a daily base after every beep. It is expected this will cost a time investment of approximately 15 minutes per day. The questionnaires are generally experienced as a small burden (in previous research performed by this department). Participation is not associated with health risks.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* good understanding of dutch language
* smartphone user

Exclusion Criteria:

* psychiatric diagnosis
* pregnancy
R-5280 in Newly Diagnosed Patients with Type 1 Diabetes

Evaluating the adverse events and tolerance of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients

Double blinded, placebo controlled, Phase 1B study assessing the safety and efficacy of 12 weeks daily administrations of R-5280 in newly diagnosed Type 1 Diabetes adolescents

Eligibility Criteria:
Inclusion Criteria:

* Newly Diagnosed children (age 11-17 years old)
* BMI \<85%
* Diagnosed by ADA criteria with T1D within 2 years
* Accepted to adhere to a healthy diabetic diet as recommended by the ADA

Exclusion Criteria:

* Monogenic forms of diabetes or type 2 diabetes
* History of ongoing infection or antibiotic treatment within the past four (4) weeks
* History of immunocompromised, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past six (6) months
* History of chronic gastrointestinal disease, possible or confirmed celiac disease
* Pregnancy or possible pregnancy
* Allergy to corn (prebiotic), milk allergy, soy (present in the MMTT meal) or their products
* Participation in other intervention research trials within the past three (3) months
* Anticipated major change in diabetes management during the study (e.g., change from injections to insulin pump therapy or new continuous monitor usage, all known to significantly alter glycemia)
* Children consuming a high-fiber or vegetarian diet (consuming three (3) or more servings of high fiber foods on four (4) or more days per week) or any fiber supplements will be excluded (to be assessed at screening)
* Any COVID vaccines within 30 days prior to Day 1
Osteoarthritis and Body Composition: Evaluation of Systematic Mediators

The purpose of this study is to examine the relationship between body composition and knee osteoarthritis, and effects of inflammatory, metabolic, and hormonal factors.

Banked serum and urine specimens obtained from NIA Baltimore Longitudinal Study on Aging (BLSA) participants with and without knee OA will be used to determine inflammatory, metabolic, bone and joint biomarkers in an observational, case-control study. This study will be limited to BLSA data and samples that have already been acquired and stored.

The specific aims of this study are to:

1. Examine the association between prevalent radiographic osteoarthritis (OA), concurrently obtained inflammatory and metabolic mediator levels and change in bone density and bone markers over time subsequent to radiographic classification.
2. Determine levels of inflammatory, metabolic and bone markers, and body composition when radiographic OA was absent, and examine their relationship to the development of radiographic knee OA.

Adjustments will be made for age, gender, body mass index and level of physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Participants of the BLSA who have had 1 or more DXA scans AND who were either classified as having radiographic knee OA (Kellgren \& Lawrence 2 or higher) or as having no radiographic knee OA on two or more xrays (KL 0-1)

Exclusion Criteria:

* Diagnosis of rheumatoid arthritis
* Diagnosis of malignancy
* Reported use of prednisone and other immunosuppressive medications or insulin
Access to Infertility Services: Clinic Perspective

Since the identification of the human immunodeficiency virus (HIV) and the acquired immunodeficiency syndrome (AIDS) in the 1980s, there have been significant advances made in the management and long-term prognosis for infected individuals. Currently, with the advent of highly active antiretroviral therapy (HAART), HIV-positive individuals may live a healthy and productive life for years to decades after diagnosis. As life expectancy has increased, this group of people has begun to engage in family planning. This has created a need for access to advanced reproductive technologies and fertility treatments. While attempting to achieve pregnancy, utilization of these services can help to minimize the risk of transmission in serodiscordant couples, and can allow treatment of subfertile couples. Access to these services may be limited in Ontario for a variety of reasons. The purpose of this study is to determine the access to infertility clinics and services in Ontario for couples in which one or both partners is infected with HIV.


Eligibility Criteria:
Inclusion Criteria:

* All Ontario clinics offering advanced reproductive/infertility services

Exclusion Criteria:

* none
Silver Foam Dressing Superior to Porcine Xenograft in Pediatric Scalds

Prospective randomized trial where two dressings has been compared for partial thickness scald burns in children 6 months to 6 years.

Aim: The aim of this study was to compare two different treatment regimes for children with partial-thickness scald burns. Burns were treated with either a porcine xenograft (EZderm®, Mölnlycke Health Care, Gothenburg, Sweden) or a silver foam dressing (Mepilex® Ag, Mölnlycke Health Care, Gothenburg, Sweden).

Methods: A prospective randomized clinical trial including 58 children admitted between May 2015 and May 2018 for partial-thickness scalds to The Burn Centre in Linkoping, Sweden. Primary outcome was time to wound closure. Secondary outcomes were pain, need of surgery, wound infection, length of hospital stay, required dressings changes, and labour time.

Eligibility Criteria:
Inclusion Criteria:

* Partial-thickness scald burns admitted within 72 hours of injury and with burns suitable for porcine xenograft according to the burn surgeon on duty were eligible and enrolled after (guardians) consenting to participate.

Exclusion Criteria:

* Children with other severe concomitant cutaneous trauma, skin disease, or children with a known hypersensitivity to silver.
Assessing a Novel Virtual Environment That Assists With Activities of Daily Living

This Phase 1 study looks at how a new videogame-based program can help residents and care partners prepare for ADLs in a fun way with minimal risk, potentially reducing escalating problems associated with ADL completions.

Central themes in person-centered care are dignity/respect/choice for the care recipient.

This Phase l clinical study is a minimal risk study that focuses on how the new technology can support and amplify these principles, while assisting care staff.

The investigators will use a novel digital health device developed with user-centered design principles, mirroring a range of evidence-based non-pharmacological interventions for people living with Alzheimer's disease and its related dementias (AD/ADRD). This is a purpose-built virtual world depicting activities of daily living (ADLs). It contains interactive engagement stimuli, including customized digital artifacts that hold meaning to the person.

The investigators hypothesize that undertaking ADL-related virtual activities will support completions of actual ADLs, thereby increasing effectiveness and improving care outcomes.

Aim 1: Feasibility Successful outcomes are \>55% participation rate and a statistically significant difference between assessments of participation and non-participation, indicating tolerability and acceptability of routine interventions.

Aim 2: Effectiveness

Successful outcomes are:

* a reduction in ADL-related care challenges compared to baseline
* reduced time spent on the evening ADLs compared to baseline
* a reduction in negative response behaviors associated with the ADL
* greater interest in the ADL
* a positive shift in care staff attitudes

Eligibility Criteria:
Inclusion Criteria:

The subject will have a diagnosis of AD/ADRD, or symptoms of an undiagnosed AD/ADRD as observed by professional care staff and confirmed by the head of clinical care. The investigators will neither include nor exclude participation based on cognitive test scores. The subject will have had challenge(s) completing one or more ADLs in the previous month, as discussed at staff meetings, referenced in care plans, or observed/experienced by direct care staff.

Other specifications:

* Understand English or Russian.
* Can sit comfortably for at least 15 minutes in a chair/wheelchair at a table or propped up in bed or princess chair with a tray table
* Are not known to be in pain
* Have good vision, or good corrected vision (i.e., glasses)
* Have good hearing, or good corrected hearing (i.e., aids)
* May sometimes have anxiety or agitation when undertaking ADLs.

Exclusion Criteria:

Ineligible subjects are those with significant non-AD/ADRD neurological, psychiatric, or physical impairment or those who are totally dependent upon others for ADLs.
The Effect of Kinesiology Taping on Lumbar Region Structures and Balance in Transfemoral Amputees

With the initiation of prosthesis use following lower extremity amputations, the body shows biomechanical changes according to the amputation level, and as a result, it develops adaptation mechanisms on both the healthy and ampute sides. It has been reported that the most common secondary pathology caused by these mechanisms developed to compensate the amputated side is lower back pain and adaptation mechanisms vary according to the presence of pain. Adaptation strategies in transfemoral amputees cause permanent changes in the connective tissue structure properties of the toracolumbar region and reduce the contribution of these structures to dynamic stability. It has been reported that with the fascia correction technique, one of the kinesiological taping techniques, the connective tissue fiber alignment can be rearranged and the degree of stiffness can be reduced. Before the intervention, biomechanical properties of the toracolumbar region structures with MyotonPro and postural stability measurements with TekScan will be taken.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-60
* Having unilateral transfemoral amputation
* Using prosthesis for at least 6 months
* Good prosthesis comfort

Exclusion Criteria:

* Body mass index\>30
* Having a history of surgery in the lumbar region in past 6 months
* Participating in a physiotherapy and rehabilitation program for a low back pain past six months
* Neurological and / or orthopedic disorders other than amputation
* Having low back pain for at least 3 months before amputation
Investigation of the Relationship Between Executive Functions and Occupational Performance of Children with Duchenne Muscular Dystrophy

The effects of Duchenne muscular dystrophy and its treatments on executive functions and occupational performance are under-mentioned in the literature. The researches believe that developmental and cognitive research is needed to identify interventions for children with DMD to identify and adapt to both individual and social environments, including self-care, productivity and leisure activities. Therefore, the aim of this study was to examine executive functions and occupational performance in children with DMD and compare them with healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with DMD
* Volunteering to participate in the study by their parents and reading and signing the informed consent form

Exclusion Criteria:

* Having a neuromuscular disease other than DMD and/or another diagnosed neuromuscular disease accompanying DMD
* The family and/or the child has problems with cooperation in completing the assessments for any reason
* Difficulty understanding and speaking the Turkish language
Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke

This study, E-COMPASS is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 75 subacute stroke patients with unilateral motor dysfunction. Primary objective is to demonstrate the efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of FMA at baseline) in patients with subacute stroke.


Eligibility Criteria:
Inclusion Criteria:

1. 1st cortical or subcortical unilateral infarction (supratentorial lesion)
2. Confirmed by CT or MRI
3. Subacute stage: less than 1 week
4. Moderate to severe motor function involvement-total of FMA: 0-84
5. Age: between 18 and 80 years
6. Inpatients

Exclusion Criteria:

1. Progressive or unstable stroke
2. Pre-existing and active major neurological disease
3. Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia
4. A history of significant alcohol or drug abuse in the prior 3 years
5. Advanced liver, kidney, cardiac, or pulmonary disease
6. A terminal medical diagnosis consistent with survival \< 1 year
7. Substantial decrease in alertness at the time of randomization, defined as score of 2 on NIH Stroke Scale
8. Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
9. Any condition that would represent a contraindication to Cerebrolysin, including allergy to Cerebrolysin
10. Current enrolment in another therapeutic study of stroke or stroke recovery
11. Total serum bilirubin \> 4 mg/dL, alkaline phosphatase \> 250 U/L, SGOT/AST \> 150 U/L, SGPT/ALT \> 150 U/L, or creatinine \> 3.5 mg/dL; or cardiopulmonary deficits large enough to interfere with reasonable participation in physiotherapy during the trial.
12. Previous porcine brain peptide administration history
Teledentistry Mobile Photos Versus Conventional Clinical Examination for Dental Caries Diagnosis

Teledentistry is an intervention that can boost chances for the new primary healthcare paradigm, bringing service delivery and accessibility to new levels. Evidence-based studies have reported that Teledentistry improves access to dental care in rural, inaccessible areas to disadvantaged populations.

The advantage of choosing Teledentistry as a dental caries screening tool is its viability in increasing oral health care to underserved areas, increasing equity, and reducing oral disease burdens in children. Furthermore, photographic images and prints of children's carious teeth can be used to motivate parents/guardians to seek dental treatment and institute preventive care. Only a teledental assistant is needed for the imaging, eliminating the need for highly skilled professional human resources. Instead, dental professionals can be better utilized in dental hospitals/clinics.

Eligibility Criteria:
Inclusion Criteria:

1. Children between 6-12 years old (mixed dentition)
2. Medically free from systematic conditions

Exclusion Criteria:

1. Uncooperative children
2. Children with orthodontic appliances at time of treatment
Strength-based Tailored-Exercise Program at Home for Geriatric Patients

This study focuses on the "Strength-based Tailored-Exercise Program at Home (STEP@Home)" aimed at improving health outcomes for geriatric patients at risk of hospitalization-associated functional decline. It is a sequential mixed-method study that combines quantitative and qualitative approaches.

This is a sequential mixed-method study, including a multi-site randomized controlled trial to evaluate the effects of the 20-week STEP@Home program and a subsequent descriptive qualitative study to explore the subjects' experience of program engagement. An overview of the timeline is given in Figure 1. Block randomization with block sizes of 4, 8, and 12, using a restricted shuffled approach with a computer-generated random sequence, will randomly allocate the subjects to receive either STEP@Home or usual care at a 1:1 ratio.to develop the STEP@Home intervention, integrating a strength-based, tailored exercise regimen for elderly patients post-hospital discharge. It addresses hospitalization-associated functional decline (HAFD) by engaging patients in sustainable self-practice of physical exercises at home. The study employs empowerment strategies, lifestyle-integrated functional exercises, and optimized tele-platform use to maximize therapeutic benefits. By focusing on empowering patients through sustainable self-practice of physical exercises at home, it aims to enhance physical functions and improve health-related quality of life. The study also has significant real-world implications, potentially offering a scalable, effective solution for the broader geriatric population to manage HAFD, thereby reducing healthcare costs and improving overall well-being. The research intends to assess the program's impact on physical functions and health-related quality of life, utilizing a sequential mixed-method approach for a comprehensive evaluation.

Eligibility Criteria:
Inclusion Criteria:

* i) aged 60 or above
* ii) has an acute hospitalization and the length of hospital stay is of ≥ 2 days2,
* iii) has risk of functional decline in 3 months following hospitalization as measured by the Screening for High-Risk Patients (SHERPA) score of \>4.5. SHERPA is a brief measure to identify the high risk by screening for the risk factors, including old age, poor health perception, IADL dysfunction, mild cognitive impairment and fall in the previous year.
* iv) discharged home without any referral for exercise-based rehabilitation
* v) has a Smartphone to access video calls
* vi) consented to participate.

Exclusion Criteria:

* i) admitted with a disabling condition leading to significant functional loss such as stroke,)
* ii) bed-bound or chair bound
* iii) with conditions contradictory to exercise training (e.g., acute muscular-skeletal problem, acute and unstable cardio-respiratory disease, etc),
* iv) engaging in moderate or vigorous exercise (\>60min/week) in the past 6 months.
Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

This study intends to assess the ability of contrast-enhanced ultrasound in the detection of benign and malignant ovarian masses compared to unenhanced ultrasound.

By using an intravascular contrast agent, this noninvasive and feasible imaging technique will allow the investigators to define specific microcirculation patterns in 100 women with ovarian lesions.

The intravascular contrast agent properties will be compared between benign and malignant adnexal masses.

The final purpose of this ultrasonography is to allow the early detection of tumors and to improve the characterization between benign and malignant lesions.

SonoVue (Sulphur hexafluoride microbubbles) is a microbubbles preparation that is stable, resistant to pressure and specifically designed to be used as a contrast agent for ultrasound imaging.

Study design : one contrast-enhanced ultrasonography is proposed before any surgery to patients with ovarian mass.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Patient with adnexal mass detected by ultrasound
* Any programmed surgery

Exclusion Criteria:

* Any contraindication to surgery
* Injection of another contrast agent within 24 hours before the study examination
* Pregnancy, breastfeeding
* Patient known to have a coronary syndrome
* Unstable angina and myocardial infarction
* Acute cardiac failure, Class III/IV cardiac failure
* Severe rhythm disorders
* Acute endocarditis
* Prosthetic valves
* Patient previously having received an investigational drug within 30 days prior to admission into this study
Intravenous Dexmedetomidine for Cesarean Section

Nervous, anxiety, fear and other psychological reactions always appears in parturients during cesarean section. This study intends to investigate the effectiveness and safety of dexmedetomidine combined with butorphanol tartrate for postoperative analgesia and breastfeeding after caesarean section.


Eligibility Criteria:
Inclusion Criteria:

1. Parturients who had successfully breastfed a prior infant and planned to breastfeed after this delivery were screened for eligibility.
2. Parturients undergoing elective caesarean delivery under epidural anaesthesia
3. ASA I and II parturients aged 18-45 years, with singleton gestation.
4. Parturients with verbal and written mandarin
5. Parturients who want to use PCA intravenous analgesia and can use the pump correctly
6. written informed consent.

Exclusion Criteria

1. Multiple gestation.
2. A history of allergy to dexmedetomidine or other study drugs
3. Cardiovascular disease (basic HR\<50bpm or SBP\<100mmHg)
4. Opioid drugs abuse.
5. BMI more than 35 kg/m2
6. Conditions that preclude spinal anesthesia.
7. Preeclampsia or epilepsy.
8. A history of neuromuscular disease.
9. Epidural anaesthesia was unsuccessful.
10. The parturients, whose surgery ended after 11 a.m.
A Prospective Study of Clinical Factors Affecting Disease Progression and Treatment Results of Patients With Tumors of the Prostate, Bladder and Kidney.

Identifying clinical factors such as medication, background diseases and blood tests that effect the course of disease in cancer patients can help physicians to better decide on the patient's treatment plan. The study seeks to identify and analyze relevant clinical factors that effect the course of the disease and the results of treatment in patients with cancers of the prostate, bladder and kidney.


Eligibility Criteria:
Inclusion Criteria:

* All patients with prostate, bladder or kidney cancer that are being treated at the Meir Medical Center and are over 18 years of age.

Exclusion Criteria:

* Patients under the age of 18