cyrilzakka/clinical-trials huggingface dataset:
Calling All Dads! Evaluation of APAs ACT Program: Engaging Fathers to Prevent Adverse Childhood Experiences

The goal of this observational study is to assess the American Psychological Association's ACT Raising Safe Kids program with male caregivers. The main question\[s\] it aims to answer are: • Will male caregivers in the ACT Raising Safe Kids program report lower child maltreatment, rates of interpersonal violence, and youth aggression. • Does the ACT RSK program have a positive return on investment and will children and caregivers in the ACT RSK condition have a higher quality adjusted life years. Participants will complete four surveys over time and attend the 9-week ACT Raising Safe Kids program. Researchers will compare survey responses from male caregivers taking the ACT Raising Safe Kids classes to male caregivers not taking ACT Raising Safe Kids classes to see if there are changes in anger regulation, family conflict, parent-child conflict, and relationship satisfaction.

The overall goal of the proposed 3-year project is to determine the efficacy and cost-benefit of ACT Raising Safe Kids, an evidence-based child maltreatment (CM) prevention program to prevent multiple forms of violence by male caregivers and their children. The program, ACT Raising Safe Kids (ACT), was developed by the American Psychological Association and identified in the Center for Disease Control \& Prevention's technical package, Preventing Child Abuse \& Neglect, as a promising strategy to prevent child maltreatment. Evidence suggests the ACT program reduces coercive, harsh, and physically aggressive parenting practices; increases positive, nurturing parenting practices; and reduces children's externalizing, aggressive, bullying behavior. While suggesting the efficacy of ACT in reducing child maltreatment, existing program evaluations have been limited by the near complete absence of male caregivers in the evaluations. This is a critical gap as male caregivers are perpetrators in nearly 50% of substantiated child maltreatment cases and are more likely to engage in harsh discipline and corporal punishment that could cause injury. The true innovation of the work lies in examining the potential of ACT to additionally prevent intimate partner violence (IPV) perpetration by male caregivers and subsequent youth violence (YV) by their children. To date, no evaluation of ACT has examined the combined prevention effects on CM, IPV, and YV among men or women.

Eligibility Criteria:
Inclusion Criteria:

* Full or partial custody of a child between the ages of one and ten years. Must read English or Spanish.

Exclusion Criteria:

-
A Study to Learn More About the Safety of Damoctocog-alfa-pegol When Used in Routine Medical Care in Korean Participants With Hemophilia A

In this study, researchers will observe and study the data from participants with hemophilia A who receive damoctocog alfa pegol as prescribed by their doctors. Participants will not receive any advice or changes to their healthcare during the study.

Hemophilia A is a genetic bleeding disorder. It is caused by the lack of a protein called clotting factor 8 (FVIII) that helps blood to clot properly. Lack of FVIII can result in excessive blood loss or bleeding inside the body after being injured or having surgery.

The study drug, damoctocog alfa pegol, can be used to prevent or treat bleeding episodes by replacing missing FVIII in the body of people with hemophilia A. It is already approved for people with hemophilia A who are at least 12 years old and have previously used other hemophilia A treatments.

Through this study, researchers want to learn more about its safety in a real-world setting.

The participants will receive damoctocog alfa pegol as prescribed by their doctors during routine practice according to the approved product information.

The main purpose of this study is to learn more about how safe damoctocog alfa pegol is in Korean participants with hemophilia A who previously used other hemophilia A treatments. To do this, researchers will collect information about any medical problems participants have during their treatment.

Data will be collected from December 2023 to March 2026 and cover a period of about 8 months for each participant. Data will come from participants' health records and information collected during their routine clinic visits.

In this study, only available data from routine care will be collected. No visits or tests are required as part of this study.


Eligibility Criteria:
Inclusion Criteria:

* ≥12 years of age with hemophilia A
* Previously treated with FVIII concentrate(s) (plasma derived or recombinant)
* Patients who have been treated with Jivi (damoctocog alfa pegol) and those for whom the decision to initiate treatment with Jivi was made as per physician's routine treatment practice with any kind of treatment modality (on-demand, prophylaxis, etc.)
* Written informed consent from subject or legal representative; assent from subject when appropriate

Exclusion Criteria:

* Contraindication according to the local authorized indication (including known hypersensitivity to the drug substance or any of its components (e.g., mouse or hamster protein))
* Patients participating in an investigational program with interventions outside of routine clinical practice
* Patients with any other diagnosis of bleeding/coagulation disorder other than hemophilia A
* Patients on immune tolerance induction treatment at the time of enrollment
Safety and Efficacy of Multiple Doses of BT061 in Patients With Moderate to Severe Chronic Plaque Psoriasis

This Phase II clinical study is to test safety and efficacy of BT061 against psoriasis given as repeated doses.

Patients are enrolled into escalating dose levels. Improvement of PASI, physician's global assessment and itching score is evaluated after administration of BT061 or placebo. Safety data are assessed by an independent data and safety monitoring board (DSMB).

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with moderate, moderate to severe or severe chronic plaque psoriasis diagnosed ≥ 12 months prior to Screening.
* BSA (Body surface area) involvement \> 10% for more than 6 months.
* PASI ≥10.
* Age ≥ 18 to ≤ 75 years.
* Body mass index (BMI) of 18-30 kg/m2 with a body weight between 50 and 130 kg.

Exclusion Criteria:

* Erythrodermic, guttate or palmar pustular psoriasis (mixed forms may be admissible if chronic plaque psoriasis clearly remains the predominant diagnosis
* Treatment with a biological within less than 30 days or within less than 5 half-lives of the respective compound prior to administration of BT061/placebo.
* Serious local (e.g. abscess) or systemic infection (e.g. pneumonia, septicaemia) within 3 months prior to the administration of BT061 or placebo.
* Presence or history of clinically significant immune deficiency or autoimmune disease (except psoriasis).
* Positive diagnosis for acute or chronic infections (i.e. Hepatitis C Virus \[HCV\], Hepatitis B Virus \[HBV\], Human Immunodeficiency Virus \[HIV\]) at Screening visit.
Exploring the Role of Serum Methylmalonic Acid (MMA) in Breast Cancer

This project aims to investigate the role of MMA in breast cancer. To this end, we will measure MMA on serum samples collected at the time of breast cancer diagnosis, to investigate the role of MMA in predicting long-term recurrence risk, response to neoadjuvant chemotherapy, and its association with age and clinical frailty.

This project aims to investigate the role of MMA in breast cancer. To this end, we will measure MMA on serum samples collected at the time of breast cancer diagnosis, to investigate the role of MMA in predicting long-term recurrence risk, response to neoadjuvant chemotherapy, and its association with age and clinical frailty. If the role of baseline serum MMA in therapy resistance and/or metastasis is confirmed, our study could be further extended by evaluating SOX4 expression in the tumor tissues (SOX4 is activated by MMA, and SOX4 induces EMT (epithelial to mesenchymal transition) and the metastasis process.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients older than 18 years at diagnosis.
2. First diagnosis of invasive breast cancer.
3. All pathological parameters are available to identify histological subtype according to standard procedures.
4. Availability of frozen serum samples at diagnosis.
5. Voluntarily signed Informed Consent obtained before blood drawing for biobanking was performed.

Exclusion Criteria:

1. Pregnant at diagnosis.
2. stage 0 disease (in situ).
3. Bilateral BC at diagnosis or multifocal unilateral BC with different histology.
4. Other subtypes than Invasive ductal carcinoma.
5. Prior breast cancer.
The Effect of Combination Lumacaftor and Ivacaftor on Markers of Hyperglycemia

The purpose of this research study is to find out if the combined therapy lumacaftor-ivacaftor affects glycemia in patient with cystic fibrosis.

This is a single center, open label study. Patients will have 1 visits at the Diabetes Research Center (DRC), or Clinical Research Center (CRC).

The participants will have been previously screened to make sure they are candidates for the study. These patients will be contacted prior to their first visit to discuss enrollment in the study.

At the study visit the participant will come to the CRC or DRC for a research visit. The following will occur at this study visit: informed consent; brief medical history; weight and height; vital signs and blood pressure; blood draw for DNA extraction, A1c and an extra research tube for storage. This will be scheduled at a time that is convenient to the patient.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years old or greater
2. Patients diagnosed with cystic fibrosis (CF), genotype homozygous Phe508del
3. Subject has been started on lumacaftor-ivacaftor for clinical reasons, with no contraindication for starting the drug\* \* Contraindications for taking drug include abnormal liver enzyme tests, renal dysfunction, pregnancy or nursing mothers

Exclusion Criteria

1. Does not have a HgbA1c within 1 year prior to starting medication.
2. Has not been on the combination therapy for at least 2 months
Effect of Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function

Ideally, the postoperative inflammatory response is part of a well-orchestrated mechanism that contributes to tissue healing and rapid recovery. An exaggerated uncontrolled inflammatory response, however may lead to catabolism, tissue damage and organ failure. Omega-3 fatty acids may provide a means to alter cellular immune responses to the benefit of the patient. When omega-3 fatty acids are incorporated into membranes of inflammatory cells, they trigger intracellular signalling pathways that result in a less pro-inflammatory response. They modify gene and protein expression, modulate membrane protein activity and act as a reservoir for bioactive molecules. They also have a strong anti-inflammatory effect by mediating resolution of the inflammation. Furthermore, omega-3 fatty acids improve erythrocyte function, which is vital for an adequate microcirculation, tissue oxygenation and wound healing.

The investigators hypothesize that the perioperative administration of intravenous omega-3 fatty acids results in a rapid incorporation in immune cells and erythrocytes, thereby reducing the postoperative inflammatory response and improving erythrocyte function in patients undergoing colorectal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients (male or female) undergoing elective laparoscopic surgery for colon cancer
* Age between 60 and 80 years
* BMI between 20 kg/m2 and below 30 kg/m2
* Written informed consent

Exclusion Criteria:

* Participation in or having participated in another clinical trial within the previous 3 months
* Indications for continuously use of anticoagulant medication and no possibility to stop these medication perioperatively, for example patients with an artificial heart valve
* Pre-operative Hemoglobin\<5.0 mmol/L
* Metastatic disease
* Very poor peripheral venous access
* Current history of inflammatory or infectious disease
* The use of anti-inflammatory drugs
* The use of thyroid medication
* The use of fish oil products or fish consumption more than 2 times a week
* Contra-indication for the use of Omegaven-Fresenius, including:
* General contra-indications for parenteral nutrition
* Allergy to fish or egg protein.
A Multicentre Trial on the Effectiveness of Physical Rehabilitation of Patients With Coronary Artery Disease: Aerobic Interval Training Versus Moderate Continuous Training.

Cardiac rehabilitation, including physical training, has become accepted treatment following myocardial infarction, coronary stent implantation and coronary bypass operation. Besides modifying patients' risk profile for future coronary problems, the focus is on improving exercise capacity. The ability to be able to perform at a higher maximal level is a strong predictor for outcome (new cardiovascular events and mortality). The main purpose of this study is to evaluate whether aerobic interval training outweighs more classical moderate endurance training in improving exercise capacity. During interval training, patients perform exercise at high intensity, but for only a couple of minutes and then recover at a lower intensity. Such intervals are repeated. Preliminary evidence from smaller studies suggests that this type of training leads to a larger increase in exercise capacity, compared to the more traditional endurance training at moderate intensity.

In addition, mechanisms that might explain how this improvement is achieved, as well as safety and impact on quality of life will be studied.


Eligibility Criteria:
Inclusion Criteria:

* patients with CAD (post-PCI, post-MI, post-CABG) and a left ventricular ejection fraction (LVEF) \> 40%
* the presence of CAD is defined as prior angiographically documented stenotic lesion(s) of \> 75%, or documented myocardial infarction (biochemical, ECG, echocardiographic documentation).
* patients are on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 4 weeks
* in practice, patients will have been hospitalized at least 4 weeks prior to participation in the training programme because of PCI, MI or CABG

Exclusion Criteria:

* significant intercurrent illness last 6 weeks
* known severe ventricular arrhythmia with functional or prognostic significance
* significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing
* recent CABG (\< 30 days)
* other heart disease that limits exercise tolerance (valve disease with significant hemodynamic consequences, hypertrophic cardiomyopathy etc.)
* co-morbidity that may significantly influence one-year prognosis
* functional or mental disability that may limit exercise
* a habit of regular vigorous exercise or participation in a programme of exercise training less than 3 months before inclusion
* acute or chronic inflammatory diseases or malignancy, the use of anti-inflammatory drugs or immune suppression
* glomerular filtration rate (GFR) \<25ml/min/1.73m2
* hemoglobin \< 10g/dl
* severe chronic obstructive pulmonary disease
* participation in another clinical trial
Influence of Modified Diet, Exercise and Electrical Swallowing Muscle Stimulation on Swallowing Function and Quality of Life in Elderly Patients With Oropharyngeal Dysphagia

Tasks of biomedical research:

1. To determine the severity of oropharyngeal dysphagia and the risk of aspiration in elderly patients.
2. To evaluate the quality of life of older patients with oropharyngeal dysphagia by performing validation of the Lithuanian version of the quality of life questionnaires in patients with oropharyngeal dysphagia.
3. To evaluate the severity of oropharyngeal dysphagia in elderly patients, the risk of aspiration, and quality of life after interventions.

Data on the sex, age and disease of the swallowing disorder will be collected. No processing of other personal data and health indicators is planned. All data will be collected in questionnaires. The data will be depersonalized by giving the patient a code.

The results and conclusions of the research will be described in the doctoral dissertation and will be used for scientific articles.


Eligibility Criteria:
Inclusion Criteria:

* Patients 60 years of age and older;
* Swallowing disorder suspected during hospitalization - oropharyngeal dysphagia;
* Patient's written consent.

Exclusion Criteria:

* severe oropharyngeal dysphagia (when feeding into the stomach through a nasogastric tube is required);
* Significant respiratory or heart failure: dyspnoea (respiratory rate\> 20 rpm, SpO2 \<90%), tachycardia (HR\> 100 rpm);
* very severe malnutrition (severe exhaustion, severe signs of sarcopenia);
* final stage of oncological disease;
* severe dementia (Short Mental Test (MMSE) \<10 points);
* Ingestion assessment with a fibroendoscope (FEES) did not reveal any swallowing problems (no dysphagia).
Action Selection and Arm Rehabilitation After Stroke

After stroke, individuals often have persistent difficulty using the arm and hand in everyday functional tasks that reduces quality of life. Currently available rehabilitation techniques are not adequate and new protocols are needed that are based on an understanding of how brain regions work together to produce skilled movement. This research project aims to improve our understanding of how the brain controls movement after stroke and determine whether a period of motor practice that targets specific brain regions through the addition of action selection demands leads to improved arm function. We hypothesize that arm motor function and the ability to efficiently activate the action selection motor circuit during movement will improve after training.

Rehabilitation of arm impairment after stroke includes the repetitive practice of functional tasks. In healthy adults, planning plays a vital role in the control of skilled movement, however, the behavioral and neural correlates of planning have largely been unexplored in individuals recovering from stroke. Action selection is an important motor planning process that engages dorsal premotor cortex (PMd) in controls. While PMd activation is a commonly reported neural correlate of motor recovery after stroke, the role of PMd in action selection and motor training are not known. Therefore, the purpose of this study is to determine the effect of training that includes action selection demands on the behavioral and neural correlates of movement after stroke. Thirty-eight individuals in the chronic phase of stroke will be recruited. After completion of clinical measures of impairment and function, all participants with stroke will complete a motor action selection task and functional MRI followed by arm training. Arm training will consist of three weeks (15 sessions) of arm motor training (1.5 hours per session) that includes action selection demands on movement. Follow-up clinical testing will occur at the end of treatment and three weeks later.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Had stroke at least 6 months ago
* Right-hand dominant prior to stroke
* Some continued arm and hand weakness
* Some ability to move the arm and hand that is weaker from the stroke

Exclusion Criteria:

* Acute medical issues that would interfere with participation
* Another neurologic diagnosis that may impact movement (e.g. Parkinson's Disease)
* Cannot undergo MRI scanning
* Severe apraxia or hemispatial neglect
* Pain in the arm that interferes with movement
* Difficulty maintaining attention or following directions
Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy

The aim of the study was to compare the renoprotective effect of a long acting calcium antagonist (nisoldipine) with an angiotensin converting enzyme inhibitor (lisinopril)in type 1 diabetic patients with diabetic kidney disease. In total, 51 patients were randomised to treatment with one of these drugs for 4 years. Changes in kidney function, blood pressure and urinary excretion of albumin were measured every 6 months


Eligibility Criteria:
Inclusion Criteria:

* diabetic nephropathy, type 1 diabetes, hypertension

Exclusion Criteria:

* child bearing potential, non-diabetic kidney disease, malignancy
Clinical Effect of Acupuncture in Neurodegenerative Diseases on Traumatic Brain Injury Patients

Traumatic brain injury (TBI) is an altered brain function caused by an external force, which may annually have 69 million incidence cases all over the world. Increasing evidence suggests that TBI may be a major risk of beta amyloid (Aβ)-associated neurodegenerative disorders, such as Alzheimer's disease, frontotemporal dementia, and Parkinson's disease. Investigations from brain imaging studies revealed that Aβ density maps of TBI patients overlapped with those with Alzheimer's disease, and increased Aβ density not only associated with prolonged TBI duration but also associated with decreased white matter integrity. It has been suggested that the axonal injury and cerebrovascular dysfunction due to TBI may associate with the elevated level of Aβ peptides. The increasing accumulation in Aβ due to TBI may contribute to the initiation of the pathological alterations in neurodegeneration diseases. Recent animal studies suggest that acupuncture may promote regeneration of nerves in injured tissues and reduce the concentration of Aβ in brain. Moreover, recent clinical trials also indicate that acupuncture may improve the vascular cognitive impairment due to cerebral small vessel disease. Thus, acupuncture treatment on TBI may not only be of benefit for the TBI recovery but also act to interrupt the pathological changes in these neurodegenerative diseases.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 20 years old
2. GCS score \> 8
3. loss of consciousness \< 24 hr
4. the physical condition is suitable for acupuncture treatment
5. having adequate competency for understanding the study and a willingness to sign the written informed consent forms
6. be able to commence the acupuncture intervention within 2 weeks after TBI diagnosis

Exclusion Criteria:

1. medical history of neurological, cardiovascular events, e.g., epilepsy, stroke, major depression or anxiety
2. a history of the mental disorder, e.g., major depression or anxiety
3. other major medical conditions, e.g., active cancer, uncontrolled diabetes, amputation
4. receipt of acupuncture within the 6 months prior to study entry
5. patients with pacemaker or metal graf
Ankle Equinus Contracture Treated With Dynamic Splinting

The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is effective in treating contracture for patients with Ankle Equinus secondary to diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Previous Diagnosis Diabetes Mellitus
* Reduced flexibility in AROM of extension in the ankle
* Less than 10º Maximal, Active Dorsiflexion, while upright
* Impaired gait pattern

Exclusion Criteria:

* Previous surgical treatment for this pathology
* Previous surgery of the Achilles tendon or triceps surae
* Current treatment with corticosteroids
* Current treatment with Botulinium Toxin-A (Botox), lower extremity
* Current treatment Fluoroquinolones (antibiotic medication)
* Current use of muscle relaxant medications
* Fibromyalgia
* Stroke, CVA, Brain Injury, Spinal Cord Injury, or any neural pathology causing plasticity or hypertonicity
* Current participation in manual, physical therapy
* Treatment with electrical stimulation assisting ambulation (i.e. Bioness, WalkAide, Parastep, etc.)
* Preexisting open sores on foot or leg