cyrilzakka/clinical-trials huggingface dataset:
Acute Effects of Action Observation on Neck Pain

This study aims to assess the immediate effects of action observation therapy on the cervical muscles' strength, pain intensity, tactile acuity and pain pressure threshold in individuals with chronic nonspecific neck pain.

This study is a randomized controlled trial with two arms: action observation group vs control group. The action observation group will be asked to watch videos of neck exercises with full attention and concentration and not perform any motion or execute any movement during the observation time. The control group will be asked to watch videos of a landscape.

Participants will be assessed at baseline and at post-intervention for muscle strength, pain intensity, pressure pain threshold and tactile acuity.

Eligibility Criteria:
Inclusion Criteria:

* Have nonspecific chronic neck pain, defined as a recurrent or persistent pain that lasts more than 3 months, with no trauma or etiology/diagnosis associated.

Exclusion Criteria:

* Visual and hearing dysfunction not corrected by eyeglasses/contact lenses or a hearing aid;
* Infectious diseases;
* Cervical myelopathy;
* Cervical surgery;
* Cervical fracture or/and subluxation;
* Vestibular pathology;
* Neurological disorder/deficits;
* Rheumatic autoimmune diseases;
* History of cancer;
* Severe cervical trauma.
Parent and Infant Inter(X)Action Intervention (PIXI)

The objective is to develop and test, through an iterative process, an intervention to address and support the development of infants with a confirmed diagnosis of a neurogenetic disorder with associated developmental delays or intellectual and developmental disabilities. The proposed project will capitalize and expand upon existing empirically based interventions designed to improve outcomes for infants with suspected developmental delays.

Participants will be infants with a confirmed diagnosis of a neurogenetic disorder (e.g., fragile X, Angelman, Prader-Willi, Dup15q, Phelan-McDermid, Rhett, Smith Magenis, Williams, Turner, Kleinfelter, Down syndromes, Duchenne muscular dystrophy) within the first year of life and their parents/caregivers.

The intervention, called the Parent and Infant Inter(X)action Intervention (PIXI) is a comprehensive program inclusive of parent education about early infant development and the neurogenetic disorder for which they were diagnosed, direct parent coaching around parent-child interaction, and family/parent well-being support. The protocol includes repeated comprehensive assessments of family and child functioning, along with an examination of feasibility and acceptability of the program.

The primary goal of the proposed project is to develop and test, through an iterative process, an intervention to address and support the development of infants with a rare neurogenetic condition (e.g., fragile X, Angelman, Prader-Willi, Dup15q, Phelan-McDermid, Rhett, Smith Magenis, Williams, Turner, Kleinfelter, Down syndromes, Duchenne muscular dystrophy) identified prior to emergence of symptoms. PiXI aims to utilize the foundational knowledge available around the development of and early intervention for at-risk infants to both understand the needs of and provide intervention services for families of infants diagnosed pre-symptomatically with rare neurogenetic disorders.

The investigators aim to 1) develop PIXI with a pilot sample of families, 2) test the preliminary effects of PIXI on infant and parent outcomes

Eligibility Criteria:
Inclusion Criteria:

* Infants 15 months of age or younger who have received a diagnosis which was not sought solely due to parental concerns about the infant (e.g. diagnosis due to prenatal or newborn screening, cascade testing following diagnosis of a family member).
* English must be the primary language spoken in the home because all assessment measures and intervention protocol are in English.

Exclusion Criteria:

- Infants may not be blind or have a severe hearing impairment as the intervention and assessments are not appropriate for these children.
Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain

This study aims to investigate the cognitive function of patients in the opioid reduction programme at the multidisciplinary pain centre at Zealand University Hospital Køge.

The patients will be tested before, halfway through, and after the programme.

The number of patients with chronic non-malignant pain is high and constant. An estimated 3-5% of the population use opioids daily. These patients have a lower quality of life and a higher use of healthcare services.

This leads to enormous costs, both human and economic. Many patients lose their ability to work, not only because of the pain, but also because of their treatment.

For a long period, opioids have been prescribed for chronic pain, even though the evidence is scarce.

A rising conscience about opioid use is on the way, and now, there is a tendency to reduce, rather than increase opioids.

The reasons are many: Constipation, inability to drive, a sense of drowsiness and no relief of pain, just to name a few. Furthermore, opioids may have decreased effect over time or may even lead to higher levels of pain.

Many patients are at first reluctant to start the reduction programme. Mostly because the patients may not be aware of the effects, the drugs are having on them. Many patients value their opioid treatment as positive and necessary, in spite of the many adverse effects.

The investigators wanted to test the cognitive function of patients before, during and after opioid reduction. The results can be used to help patients understand the deleterious effects of high opioid usage, and can also be used to motivate the individual patient along the way.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age and able to provide a written consent
* Participating in the opioid reduction programme

Exclusion Criteria:

* Not able to speak and understand Danish
* Patients suffering from dementia or psychosis
Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health

This study is a large population-based analysis in the United Kingdom (UK) using routine primary care data to investigate the risk of mental health conditions in children, adolescents and young adults with Inflammatory Bowel Disease, compared to those without Inflammatory Bowel Disease. The study will also compare the impacts on quality-of-life outcomes and use of healthcare services between people with Inflammatory Bowel Disease with and without mental health conditions.

This study will use routinely electronic medical record (EMR) data from primary care practices within the Optimum Patient Care Research Database (OPCRD).

Stream 1 primary objective is to compare the prevalence and cumulative incidence of mental health conditions in children, adolescents and young adults with a diagnosis of Inflammatory Bowel Disease, compared to matched population controls without a diagnosis of Inflammatory Bowel Disease. The secondary objective is to determine the severity of mental health outcomes in those with and without a diagnosis of Inflammatory Bowel Disease.

Stream 2 primary objective is to determine the impact of mental health conditions in children, adolescents and young adults with Inflammatory Bowel Disease on quality-of-life indicators, such as records for absence from work or school, unemployment, sleep disturbance and substance abuse. The secondary objectives are to compare indicators of Inflammatory Bowel Disease severity, such as medication use, surgical intervention, nutritional supplement prescriptions and markers of nutritional status including underweight or growth retardation in children and adolescents, between those with and without mental health conditions. Then to compare healthcare resource utilisation in children, adolescents and young adults with Inflammatory Bowel Disease with and without mental health conditions.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 5 years and 25 years
* Registration with a general practices (GP) contributing routinely collected electronic healthcare data to the Optimum Patient Care Research Database (OPCRD) for more than 6 months during the follow up period
* A recorded diagnosis of IBD in the clinical record (cases)

Exclusion Criteria:

• None
Clinical Investigation of Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin

Hodgkin Lymphoma patients with limited stage are commonly cured with limited chemotherapy followed by radiotherapy. Studies have shown a risk of late toxicity from the radiotherapy, such as second cancer, heart failure and lung toxicity. With proton therapy the dose to normal tissue can be minimised without compromising the dose to the tumor. The aim of our study is to investigate whether proton therapy can be delivered in a safe way to Hodgkin Lymphoma patients with less late side effects than conventional radiotherapy, while retaining the high cure rate.

This is a multicentre phase II study of PBS proton beam therapy in patients ≤60 years, with early stage Hodgkin Lymphoma treated with induction chemotherapy. The study is performed in a non-inferiority setting comparing with a historical population-based consecutive Swedish material. The control group was treated according to the same principles, except that the radiotherapy was delivered with photons.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of classic Hodgkin Lymphoma.
* Ann Arbour stage 1A, 1B or 2A.
* Both patients with and without risk factors, i.e. bulky disease, erythrocyte sedimentation rate (ESR)\>50, more than two involved sites.
* Supra diaphragmal disease.
* Age 18-60 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
* Initial staging positron emission tomography/computed tomography (PET/CT).
* Induction chemotherapy including 2 cycles of ABVD for patients without risk factors and 4 cycles of ABVD for patients with risk factors.
* For patients with risk factors a CT after 2 ABVD confirming complete remission (CR) or partial remission (PR). For patients without risk factors clinical response is sufficient at inclusion, but a CT scan is recommended before start of radiotherapy.
* Radiotherapy (RT) start not later than 6 weeks after end of chemotherapy.
* Written informed consent obtained prior to any study specific procedures.
* Women of reproductive age must agree to use contraceptives during the study treatment period.

Exclusion Criteria:

* Pregnancy.
* Serious concomitant systemic disorder endangering treatment delivery.
* More than 5mm tumour motion on 4 dimensional computed tomography (4DCT) unless deep inspiration breath hold (DIBH) is used. Not applicable if target is located outside mediastinum or photon treatment is planned.
* Clinical or radiographic stable disease (SD)/ progressive disease (PD) during induction chemotherapy.
* Not able to comply with treatment and study procedures.
* No additional active malignancy except indolent lymphoma in the bone marrow, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer.
The Impact of Snacks Which Vary Nutritionally in Their Satiating Potential on Measures of Appetite Control

The current study will examine the effect of almond consumption (0.9g/kg dose) compared to an energy and weight matched comparator food or no food on measures of appetite control including appetite sensations, energy intake and food hedonics.

Some individuals exhibit a weak satiety response to food and may be susceptible to overconsumption. Snack foods can be substantial contributors to daily energy intake, with different types of snacks exerting potentially different effects on satiety per calorie consumed. The current study will compare the effect of consuming different snack foods on measures of appetite control including appetite sensations, energy intake and food hedonics in women with a weak satiety response.

In a crossover design, female participants will consume three different mid-morning snacks: raw almonds, savoury crackers or water. Appetite sensations, energy intake, food reward and craving will be assessed under controlled laboratory conditions. Satiety responsiveness will be determined using the satiety quotient (SQ).

Eligibility Criteria:
Inclusion Criteria:

* Participants who have provided written informed consent.
* Healthy female participants aged 18-55 years.
* BMI of 18.5 - 30.0 kg/m2.
* Regular breakfast eaters.
* Not currently dieting to lose, gain or maintain weight.
* Non-smokers.
* Liking/acceptance of the study foods (≥4 on 7-point Likert scale).

Exclusion Criteria:

* Taking medication known to affect appetite within past month and/or during the study.
* Any known food allergies or food intolerances.
* Participants who do not regularly eat breakfast.
* Participants with low liking or acceptance of the study foods.
* Participants currently dieting to lose, gain or maintain weight.
* Reported history of or present eating disorder.
* BMI \<18.5 kg/m2 or \>30 kg/m2.
* Vegetarians.
Spirulina Tablets Treat Liver Fibrosis/Cirrhosis

Spirulina (Spirulina platensis, SP) is a nutrient-rich blue-green algae that has been widely studied and applied in various health fields. Its main components include spirulina polysaccharide proteins, amino acids, vitamins, and minerals, especially the eight essential amino acids that the human body cannot synthesize on its own. Spirulina is also rich in minerals such as iron, calcium, and zinc, which makes it beneficial in the prevention and treatment of several diseases. Research has shown that spirulina has potential therapeutic effects in combating tumors, obesity, diabetes, cardiovascular diseases, and anemia. In 2020, the National Health Commission of the People's Republic of China classified it as a health food supplement.

Hepatic fibrosis (HF) is a process of chronic liver disease caused by excessive repair responses to liver tissue injury due to various factors. As the fibrosis progresses, extracellular matrix in the liver accumulates, forming scar tissue that gradually replaces the normal liver parenchyma. Eventually, these pathological changes can lead to cirrhosis, portal hypertension, and even primary hepatocellular carcinoma (HCC), which may result in liver failure. Therefore, hepatic fibrosis is considered a critical precursor to cirrhosis and liver cancer.

In 2007, Elsharkawy and colleagues proposed the "hepatitis-fibrosis-liver cancer axis" theory, which emphasized that timely treatment of hepatic fibrosis is crucial to controlling the development of cirrhosis and liver cancer. However, modern medicine has yet to discover specific drugs for treating hepatic fibrosis or cirrhosis. The etiology of hepatic fibrosis is complex, involving various cellular and molecular mechanisms, thus making the in-depth study of its pathogenesis and the development of new treatments particularly urgent.

As the understanding of hepatic fibrosis continues to deepen, increasing attention is being given to the potential of natural products or health supplements in preventing and treating hepatic fibrosis. Spirulina, as a natural product with multiple biological activities, may become a promising direction for exploring new treatments for hepatic fibrosis due to its immune-regulating, antioxidant, and anti-inflammatory effects. Through further clinical and experimental research, spirulina may offer a new complementary treatment option for hepatic fibrosis.


Eligibility Criteria:
Inclusion Criteria for Patients:

* Diagnosed with liver fibrosis or cirrhosis.
* Patients scheduled for liver transplantation with a waiting time of more than 3 weeks.
* Adults aged 18 to 75 years.
* Willing to participate in the study and sign an informed consent form.
* No acute diseases or significant exacerbation of symptoms in the 4 weeks prior to enrollment.

Exclusion Criteria:

* Patients with severe comorbidities.
* Patients allergic to Spirulina tablets.
* Patients with a history of severe mental illness that could affect treatment adherence.
3-D Transcranial Ultrasound Analysis Study

The purpose of this study is to investigate real time 3-D ultrasound imaging of the brain for the diagnosis and evaluation of stroke.

The objective of this proposal is to extend our previous advances to investigate real time 3-D ultrasound imaging of the brain for the diagnosis and evaluation of stroke. Over the last decade, with the availability of color flow Doppler combined with effective ultrasound contrast agents, a renaissance has occurred in transcranial sonography as a low cost, bedside method for evaluation and management of patients with cerebrovascular disease in spite of the image degrading properties of the skull. Our hypothesis is that we can combine new generations of 2D array transducers with ultrasound contrast agents and phase aberration correction to enable real time 3D ultrasound imaging and 3D color flow Doppler of the brain with a factor of 10 improvement in spatial resolution compared to conventional transcranial sonography for improved diagnosis and evaluation of stroke.

Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

* persons \<18 years old
* pregnant or nursing women
* history of neurological disease
* congenital heart defect
* severe liver dysfunction
* respiratory distress syndrome
* hypersensitivity or an allergic reaction to blood products.
A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma

This Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.


Eligibility Criteria:
Inclusion Criteria:

* Has a histopathologically documented IDH1 mutated WHO grade II glioma according to the 2016 WHO classification.
* Has confirmed IDH1 mutation at the R132 locus by testing at the central laboratory conducted during the screening period.
* Has no prior anticancer treatment (including chemotherapy and radiotherapy) for glioma except craniotomy or biopsy.
* Has at least 1 measurable and non-enhancing lesion.
* Has an interval of at least 90 days from the latest surgery.
* Has no sign of malignant transformation including the appearance of enhancing lesions and/or rapid growth of non-enhancing lesions.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.

Exclusion Criteria:

* Has had a histopathological diagnosis of WHO grade III or IV glioma.
* Has had a contrast enhancing lesion on brain MRI.
* Has received a prior treatment with any mutant IDH1 inhibitor.
* Has received other investigational products within 28 days before the start of the study drug treatment.
* Has an active infection requiring systemic treatment.
* Has multiple primary malignancies.
* Has a history of clinically significant cardiac disease.
* Is a pregnant or lactating woman.
Active-control Randomised Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery

This is a multicentre, active-control randomized, prospective, Phase 3 study in adult cardiac surgery patients. Approximately 500 patients will be randomized at approximately 12 hospitals.

Patients will be randomized to receive either 4-factor PCC (Octaplex) or frozen plasma (FP).

The study will compare the hemostatic treatment response to Octaplex versus FP, defined as effective if no additional systemic or surgical hemostatic intervention is required from 60 minutes to 24 hours after initiation of the first treatment dose.

The study will include adult (≥18 years old) patients who undergo cardiac surgery with cardiopulmonary bypass (CPB) and require coagulation factor replacement due to bleeding post-CPB and after adequate reversal of heparin with protamine (as assessed by the surgical staff based on clinical and laboratory criteria) during surgery, and who have a known (e.g., as indicated by INR) or suspected coagulation factor deficiency.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (≥18 years old) patients undergoing any index cardiac surgery employing CPB
2. Coagulation factor replacement with PCC or FP ordered in the operating room for:

   1. Management of bleeding, or
   2. Anticipated bleeding in a patient who has been on-pump for \>2 hours or has undergone a complex procedure (e.g., aortocoronary bypass \[ACB\] plus aortic valve replacement)
3. Coagulation factor deficiency, either known to exist (e.g., as indicated by elevated EXTEM clotting time \[CT\] or INR) or suspected based on the clinical situation
4. Patients who have given written informed consent. In United States patients will provide informed consent prior to surgery. In Canada, informed consent will be obtained after surgery, in accordance with Article 3.7A of the 2018 Tri- Council Policy Statement on the Ethical Conduct for Research Involving Humans.

Exclusion Criteria:

1. Undergoing heart transplantation, insertion or removal of ventricular assist devices (not including intra-aortic balloon pump \[IABP\]) or repair of thoracoabdominal aneurysm
2. Critical state immediately before surgery with high probability of death within 24 hours of surgery (e.g., acute aortic dissection, cardiac arrest within 24 hours before surgery)
3. Severe right heart failure (clinical diagnosis ± echocardiography)
4. Known contraindications to heparin
5. PCC required for reversal of warfarin or direct oral anticoagulant (DOAC; dabigatran, rivaroxaban, apixaban or edoxaban) within 3 days prior to or during surgery
6. Known thromboembolic event (TEE) within 3 months prior to surgery
7. History of severe allergic reactions to PCC or FP
8. Individuals who have immunoglobulin A (IgA) deficiency with known antibodies against IgA
9. Refusal of allogeneic blood products
10. Known pregnancy
11. Currently enrolled in other interventional clinical trials