cyrilzakka/clinical-trials huggingface dataset:
Improving Blood Pressure Control Through the myBPmyLife mHealth Application

This study is enrolling eligible participants that have high blood pressure. Reducing dietary salt intake and engaging in regular physical activity is known to decrease blood pressure in people with hypertension. This trial will determine whether a smartwatch and a mobile health application, which together deliver notifications, can increase activity levels and reduce salt intake for people with high blood pressure. All study activities will be completed online or via a mobile medical application. Participants will not have any face-to-face visits with the study team.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported history of hypertension and no hypertensive medication changes in the last 4 weeks.
* A smartphone with a compatible Apple or Android operating system installed and able to download and use the myBPmyLife app including accepting all permissions
* A valid email address
* Fluent in spoken and written English
* Signed written informed consent. (Note that each participant must be able to consent for themselves.)

Exclusion Criteria:

* Contraindication to performing physical activity or following a sodium restriction diet. The participant must be able to walk and eat on their own without assistive devices.
* Unstable symptoms or markedly elevated BP at enrollment (defined as systolic BP\>180 mmHg, diastolic BP\>120 millimeters of mercury (mmHg))
* Known secondary causes of hypertension (e.g., adrenal insufficiency, pheochromocytoma), heart failure, or end-stage renal disease
* Difficulty using an upper arm blood pressure cuff due to biceps size or end-stage renal disease or difficulty comfortably wearing a smartwatch
* Wrist too large to wear a smartwatch comfortably.
* Daily sodium intake less than 1500 mg/day as measured by the sodium screener
* Currently pregnant or planning to become pregnant in the next six months
Regulatory Post Marketing Surveillance (rPMS) Study of Xultophy® (Insulin Degludec/Liraglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea

The aim of this study is to assess the safety and effectiveness of Xultophy® initiated according to label in adults with type 2 diabetes mellitus (T2DM) under routine clinical practice conditions. Participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 26 weeks.


Eligibility Criteria:
Inclusion Criteria:

* The decision to initiate treatment with commercially available Xultophy® has been made by the participant/Legally Acceptable Representative (LAR) and the study doctor before and independently from the decision to include the participant in this study.
* Informed consent obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Male or female, age 19 years or older at the time of signing informed consent form.
* Participants diagnosed (clinically) with T2DM and who is scheduled to start treatment with Xultophy® based on the clinical judgment of their treating physician as specified in the approved Korean-Prescribing information (local label).

Exclusion Criteria:

* Participants who are or have previously been on Xultophy® therapy.
* Known or suspected hypersensitivity to Xultophy® (the active substance or any of the excipients).
* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Efficacy and Safety Study of KN019 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

The purpose of this study is to assess the efficacy, pharmacokinetics, safety, and immunogenicity of KN019 after intravenous administration on background methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate.

This study is designed to provide efficacy data in support of the proposed claims of reducing signs and symptoms, improvement in physical function, and 1 year safety data for KN019 dosed at 5 and 10 mg/kg in patients with inadequate response to stable weekly doses of background methotrexate.

Eligibility Criteria:
Key Inclusion Criteria:

* The patient must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of rheumatoid arthritis (RA) by satisfying at least four of the seven criteria;
* Patients must have been taking methotrexate for at least 3 months with at least a weekly dose of 7.5-25 mg, and a stable dose for 28 days prior to treatment (Day 1)
* The patient must have active disease at both screening and baseline, as defined by having both:

  6 tender/painful joints on motion (out of 68 joints assessed); and; 6 swollen joints (out of 66 joints assessed); CRP ≥ 7 mg/L, or ESR ≥28 mm/h

Key Exclusion Criteria:

* Pregnant or lactating females.
* History of any other autoimmune rheumatic disease.
* Patients who have previously received CTLA4-Ig therapy for any reason.
Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial

The main purpose of this study is to determine the feasibility and effects of a 6-month tai chi exercise program as compared to a 6-month group walking program and standard care for patients with COPD that have recently completed a pulmonary rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

1. COPD defined as FEV1 (Forced expiratory volume in 1 second)/FVC (Forced vital capacity) \<0.70 or chest CT evidence of emphysema
2. Age \> 40 years
3. Any severity of COPD as defined by GOLD (Global Obstructive Lung Disease) stages 1, 2,3, or 4
4. Completion of standard pulmonary rehabilitation of at least 8 weeks duration within 24 weeks prior to study entry\* \*Defined as attending 65% of the program's sessions with a minimum of 10 sessions

Exclusion Criteria:

1. COPD exacerbation requiring steroids, antibiotics, ED visit or hospitalization within the past 2 weeks unless physician deems subject at baseline
2. Hypoxemia on walk test (O2 sat \< 85% on oxygen)
3. Inability to ambulate due to vascular or other neuromuscular conditions that would preclude a walk test
4. Clinical signs of unstable cardiovascular disease (ie. chest pain on walk test)
5. Severe cognitive dysfunction (documented Mini-Mental Status Exam ≤ 24)
6. Non-English speaking
7. Current regular practice of tai chi
8. Current diagnosis of lung cancer or treated for lung cancer within the past 5 years
9. Unstable/untreated mental health issue that precludes informed consent or otherwise affects ability to participate in the intervention
Lipid Management in Clinical Practice (MK-0524A-115)

The aim of this observational program is to generate data on the use of Tredaptive (nicotinic acid/laropiprant) for lipid management under routine medical practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patients are 18 years of age or older with lipid disorder treated with nicotinic acid/laropiprant

Exclusion Criteria:

* Patient is currently participating in a clinical trial
Psychometric Properties of the Turkish Version of the HANA in Tension Type Headache

Individuals with tension type headache


Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of tension-type headache,
* Being between 18 and 65 years of age.

Exclusion Criteria:

* Having a diagnosis of any headache disorder other than tension-type headache,
* Having a history of any systemic disease, such as malignancy, inflammatory conditions, acute fractures, surgical history, or neurological, psychological, or rheumatological disorders.
The Effectiveness of an Online Support Group in Enhancing Recovery Identity and Health-Related Quality of Life

Background Ovarian cancer poses challenges for middle-aged and older patients, impacting physical and self-conceptual aspects. A research gap exists on the impact of online support groups (SPs) on identity synthesis and Health-Related Quality of Life (HRQOL) for these patients.

Objective To assess the feasibility and efficacy of an online SG in influencing recovery identity and HRQOL in middle-aged and older ovarian cancer patients (MDOCP).

Method A four-week randomized controlled trial, followed by a three-month evaluation, was conducted, employing a mobile online SG and an offline SG both grounded in The Social Identity Model of Identity Change. Recovery identity, HRQOL, and participant engagement were utilized to evaluate the feasibility and efficacy of interventions.


Eligibility Criteria:
Inclusion Criteria:

* Older than 44 years old
* diagnosis of ovarian cancer
* expected survival time of greater than four months
* fluent in using smartphones and the WeChat mini program
* normal cognitive function
* capability to participate in follow-up surveys.

Exclusion Criteria:

* were currently participating in or had previously participated in other mental treatment groups
* had been diagnosed with any other type of cancer.
Head and Neck Positions for Endotracheal Intubation Using a Videolaryngoscope

In this study, the investigators evaluate the effect of head positions (simple extension vs. sniffing position vs. head elevation) on endotracheal intubation using a videolaryngoscope.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for general anesthesia

Exclusion Criteria:

* Limited neck extension
* Anatomical anomalies or history of surgery in the upper airway
* Weak teeth
* Risk of pulmonary aspiration
Self-efficacy Coaching for Women With Breast Cancer

This is an open, prospective, multi-center, interventional study to evaluate the benefit and efficacy of individualized self-efficacy coaching for women with high-risk early breast cancer.

In total, 6 sites will be assigned 1:1 to either the experimental arm (Group A) or the control arm (Group B). The controlled site assignment will assure a balanced site-specific QoL between both groups at baseline. All patients will be medically treated according to guidelines. The experimental Group A will in addition receive regular self-efficacy coaching.

Breast cancer represents the leading cause of cancer in women in Switzerland with around 6,000 newly diagnosed cases per year. Beside the therapy- and cancer-associated somatic illness, about one third of patients develop anxiety disorders or depression and need psychotherapeutic or psychiatric care. Women with breast cancer display the highest psychic comorbidity compared to patients with other cancer entities (40% point prevalence) .

To assist with psychological coping with the disease several psycho-oncological interventions have been established in the past decades.

Self-efficacy describes the extent or strength of one's belief in one's own ability to complete tasks and reach goals. Nagel \& Schreiber have developed an individualized self-efficacy coaching for cancer patients to mobilize and strengthen the belief in one's own ability to deal with and fight the disease. The SECOM-PSWE study evaluates the impact of regular self-efficacy coaching on the perceived self-efficacy and the quality of life (QoL) in patients with early breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Written and signed informed consent
2. Histologically confirmed early breast cancer
3. High risk patients, defined as T≥3 and/or N+ and/or G3 and/or Triple-Negative Breast Cancer (TNBC; PgR-/ER-/HER2-) at primary diagnosis
4. Eligible for systemic neo-adjuvant or adjuvant therapy
5. Age ≥ 18 years
6. ECOG 0-2
7. Expected follow-up care at site for at least 5 years
8. Expected adherence to observation and questionnaire assessment (Group A and B) as well as to study intervention (Group A)
9. Anti-cancer therapy and follow-up care according to the established guidelines
10. Fluent in written and spoken German language

Exclusion Criteria:

1. Not eligible for systemic neo-adjuvant or adjuvant treatment according to the established guidelines
2. Previous systemic anti-neoplastic therapy
3. Resection \>R0 for adjuvant patients
4. Metastases
5. Patients who decline systemic therapy according to established guidelines for personal reasons
6. Inflammatory breast cancer, sarcomas, M. Paget
7. Presence of other primary tumors within the last 5 years, except for appropriately treated, controlled, basal-cell carcinoma and cervical cancer in situ
8. Not controlled, severe, life-threatening, or prognostic unfavorable comorbidities
9. Pregnancy, lactation
10. Indication of a severe depression/anxiety disorder at baseline (PHQ 9 Score ≥15 and/or GAD-7 Score ≥15 at baseline)
11. Participation in other (non-)interventional studies or tumor registries
12. Male patients
Short and Mid-term Repeatability of Active Anterior Rhinomanometry (AAR) Measurements in Paediatric Age

Longitudinal, observational study to assess the short-term (test re-test) and mid-term (within the span of 28 days) repeatability of active anterior rhinomanometry (AAR) measures on 4 parallel groups of children with different rhinitis phenotypes, and 1 group of control (healthy) children.

Secondary objectives are: i) assessing of association between AAR, exhaled FeNO (eFeNO) and nasal FeNO (nFeNO); ii) assessing association between objective measurements (AAR, eFeNO and nFeNO) and subjective measurements (Total 5 Symptom score, T5SS).

The study is intended to obtain useful information for improving rhinitis management.


Eligibility Criteria:
Healthy volunteers (HC)

The inclusion criteria for HC are:

1. Negative bronchodilator response;
2. No major nasal septum malformations.

The exclusion criteria for HC are:

1. Upper airway infections in the previous 4 weeks;
2. Active smoker;
3. Lifetime history of asthma, rhinitis, or respiratory disease symptoms.

Children with non allergic rhinitis (NAR)

The inclusion criteria for NAR are:

1.T5SS\>5 in the last 4 weeks.

The exclusion criteria for NAR are:

1. At least one positive skin prick test for aeroallergens;
2. Upper airway infections in the previous 4 weeks;
3. Active smoker;
4. Major nasal septum malformations.

Rhinitis children, perennial allergy (PAR)

The inclusion criteria for PAR are:

1. T5SS\>5 in the last 4 weeks.
2. At least one positive skin prick test for perennial aeroallergens;

The exclusion criteria for PAR are:

1. At least one positive skin prick test for seasonal aeroallergens;
2. Upper airway infections in the previous 4 weeks;
3. Active smoker;
4. Major nasal septum malformations.

Rhinitis children, seasonal allergy, outside season (OSR)

The inclusion criteria for OSR are:

1. T5SS\>5 in the last 4 weeks.
2. At least one positive skin prick test for seasonal aeroallergens;

The exclusion criteria for OSR are:

1. At least one positive skin prick test for perennial aeroallergens;
2. Upper airway infections in the previous 4 weeks;
3. Active smoker;
4. Major nasal septum malformations.

Rhinitis children, seasonal allergy, within season (OSR)

The inclusion criteria for OSR are:

1. T5SS\>5 in the last 4 weeks.
2. At least one positive skin prick test for seasonal aeroallergens;

The exclusion criteria for OSR are:

1. At least one positive skin prick test for perennial aeroallergens;
2. Upper airway infections in the previous 4 weeks;
3. Active smoker;
4. Major nasal septum malformations.
Vestibular Function in Cochlear Implants

The objective of this study is to identify possible preoperative risk factors including genetic background and to suggest the optimal test battery of vestibular function in cochlear implant recipients

The objective of this study is to identify possible preoperative risk factors including genetic background and to suggest the optimal test battery of vestibular function in cochlear implant recipients Participants underwent standard vestibular testing including video head impulse test (vHIT), vestibular evoked myogenic potentials (VEMP), subjective visual vertical and stabilometry before and after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* profound bilateral sensorineural hearing loss meeting criteria for cochlear implantation

Exclusion Criteria:

* profound unilateral sensorineural hearing loss meeting criteria for cochlear implantation
Upper Limb Muscle Strength Models for Patients With Motor Impairment.

Upper limb motor impairments are common. They affect quality of life and can lead to dependency. They are mainly due to neurological conditions such as stroke, multiple sclerosis, and traumatic spinal cord injury. However, the contractile properties of muscle, in particular the maximum force that can be generated voluntarily (MVF) depending on joint angle and motion speed, have been mainly studied and modeled in healthy people. This study aims at developing mathematical models describing residual muscle forces in patients with motor impairments. The knowledge could guide patients' rehabilitation and could be useful for the development of robotic assistance systems that use patients\&#39; residual capacities to control the level of assistance provided.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 85
* A patient who is a member or beneficiary of a social security scheme
* Patients hospitalised at the Saint-Hélier rehabilitation centre for a stroke more than 15 days old, MS or SCI
* Patients with a motor deficit ≤3/5 on the MRC (Medical Research Council) scale in both internal-external shoulder rotation and elbow flexion-extension.
* Patient with voluntary consent to participate in this study.

Exclusion Criteria:

* Spasticity \&gt;3/4 on the Aschworth scale in the shoulder abductor or elbow flexor muscles.
* Cognitive impairment that may interfere with measurements (MOCA \&lt; 20/30)
* Presence of a pressure sore \&gt; stage 2 at the ischial level
* Recent trauma to limbs or spine
* Decompensated heart disease or other unbalanced pathology which contraindicates or may hinder isokinetic testing.
* Persons deprived of their liberty by a judicial or administrative decision
* Pregnant women, women in labour or nursing mothers.
Study on Novel Peripheral Blood Diagnostic Biomarkers for MCI Due to Alzheimer's Disease

The prevalence of Mild Cognitive Impairment (MCI) is about 15%-17%. 10%-15% of MCI progresses to Alzheimer's disease (AD) every year. The annual incidence of MCI in the normal elderly is about 1%. Peripheral Blood biomarkers is the key and difficult points in AD research. Except expensive brain β amyloid plaque imaging, few breakthroughs of early diagnosis technology of MCI due to AD can be made to facilitate clinical application. Even Tau-181 and Tau-217 were reported in this year on Lancet neurology and JAMA. We also need to study on the biomarkers upstream of pathological changes about senile plaque. The purpose of this program is to study the reliability and validity of plasma miRNAs for early diagnosis of MCI due to AD and other dementia such as DLB and FTLD. The clinical diagnosis of AD and MCI due to AD are according to the National Institute of Aging and the Alzheimer's Disease Association (NIA-AA) diagnostic criteria in 2011. Plaque imaging is used to be golden criteria for the diagnosis of AD and MCI due to AD.


Eligibility Criteria:
Inclusion Criteria:

* 2011 NIA-AA criteria of MCI due to AD or AD or - 2017 Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium or - 2001 the McKhann consensus clinical criteria for FTD (McKhann et al.)

Exclusion Criteria:

* Dementia caused by infection or substance
* Thyroid disease
Differences in Nerve Fiber Layer Between Patients With Normal- and High-Pressure-Glaucoma

The purpose of the study is to prove if there is any difference in the nerve fiber layer between patients with normal- and high-tension-glaucoma with similar structural optic nerve head parameters.

It is till now not definitely clear whether normal- and high-tension glaucoma are different forms of the same disease and whether they have similar pathogenetic mechanisms. Spectral domain optical coherence tomography (SD-OCT) is supposed to objectively evaluate retinal nerve fiber layer (RNFL) thickness. The investigators propose a study to compare the RNFL in patients with normal- and high-tension-glaucoma. In order to exclude other possible differences,which could influence the results, only patients with similar structural optic nerve head damage in both groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* persons over 18 years
* men or women
* with normal- and high-tension glaucoma

Exclusion Criteria:

* cataract
* cloudy cornea and other conditions with bad visualisation quality of optic nerve head
* optic nerve atrophy except glaucomatous
Transplantation of Ovarian Cortex to Restore Fertility

Ovarian transplantation has been shown to restore fertility.

The investigators transplant ovarian cortex previously collected from the patient prior to cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients who froze ovarian tissue

Exclusion Criteria:

* malignant cells in ovary
A Fighting Chance: Pilot Study of a Group Mentoring Intervention for Assault Injured Youth

This pilot study is a randomized controlled trial in which assault-injured 12-14 year old youth recruited from the emergency department (ED) are randomly assigned to standard care or "A Fighting Chance" group mentoring.

The goal of this project is to adapt, implement and evaluate Take Charge! (a 1:1 mentoring intervention for assault-injured youth) for a group mentoring model.

This pilot study is a randomized controlled trial in which assault-injured 12-14 year old youth recruited from the emergency department are randomly assigned to standard care or "A Fighting Chance" group mentoring that includes a violence prevention curriculum and parent sessions. Immediately post-intervention and again at six-month follow up, youth violence-related, mental health and educational outcomes using validated measures will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Injury: Eligible youth have been treated in the ED for an interpersonal intentional injuries excluding child abuse, sexual abuse, sibling fights, police fights, and other domestic violence-related fights involving relatives and/or household residents. These excluded types of violence have a different set of complex dynamics and services needs requiring separate study and intervention.
* Age: Eligible youth are age 12-14 years (i.e. up to the 14th birthday) and youths' parents/guardians are age 18 years and older.
* Mental/Physical Status: Youth and parents must have the cognitive ability to participate in the intervention. Those with severe psychopathology (i.e. severe history of mental illness with multiple psychiatric hospitalizations) or inability to comprehend questions, will be excluded.
* Language: English-speaking ability of the parent and child is necessary to enable participation in the intervention, training and assessments.
* Mentorship: Eligible youth are not currently participating in a formal mentoring program.

Exclusion criteria:

Additionally, there are youth eligibility criteria set by Y in Central Maryland policies which the investigators will follow. These include:

* Residence: Youth are not eligible if residence is outside of Baltimore City.
* Custody/child protection status: Youth are not eligible if youth have a caregiver currently involved in an ongoing custody dispute or Child Protective Services investigation. Youth are not eligible if youth live somewhere other than a residential setting with parents/guardians.
Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain

This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment of acute ankle sprain.


Eligibility Criteria:
Inclusion Criteria:

* Acute sprain of the ankle
* Injury within past 48 hours.

Exclusion Criteria:

* Pain medication taken since the injury
* Pain or instability in the same ankle due to previous ankle sprain or any other trauma.
* Ankle sprain due to a known disease affecting the ligaments

Other protocol-defined inclusion/exclusion criteria may apply