cyrilzakka/clinical-trials huggingface dataset:
A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa

FREEDOM is a multicentre, open-label, single-arm, phase 3b study in Europe that aims to enrol approximately 90 previously treated severe haemophilia A patients aged ≥12 years, currently on prophylaxis. After a run-in period of 30-45 days, patients will receive efanesoctocog alfa prophylaxis, 50 IU/kg once-weekly for 24 months (additional preventive dose not permitted). An activity tracker and an electronic patient diary will be used to collect data on physical activity, bleeds, factor dosing, pain, and injuries from screening throughout the study.

The primary objective is to describe changes in physical activities over 24 months on efanesoctocog alfa prophylaxis, with a primary endpoint of change from baseline in International Physical Activity Questionnaire (IPAQ) at month 24.

Secondary objectives include relationship between physical activity and other variables (bleeds, joint status, pain, injuries, and quality of life); changes in joint status as assessed by HEAD-US, HJHS and MRI; occurrence of bleeds, injuries, pain. Safety and tolerability of efanesoctocog alfa will also be evaluated.


Eligibility Criteria:
Key Inclusion Criteria:

* Previous treatment for haemophilia A with any marketed recombinant and/or plasma-derived FVIII for at least 150 EDs.
* Having received prophylactic treatment with any marketed recombinant and/or plasma FVIII or emicizumab per local label for at least 12 months preceding enrolment.
* Having 12 months documented pre-study treatment data regarding prophylactic treatment prescriptions and 6 months data on bleeding episodes prior to baseline visit.
* Willingness and ability to complete training in the use of the study ePD and to use the ePD in their own smartphone throughout the study.
* Willingness and ability to use the activity tracker provided by the sponsor to measure physical activity and heart rate.
* Be able and willing to administer efanesoctocog alfa intravenously at home.

Key Exclusion Criteria:

* Serious musculoskeletal and/or neurological impairment limiting the mobility and the physical ability to a degree that makes the patient unsuitable for the study as judged by the investigator.
* Other known coagulation disorder(s) in addition to haemophilia A.
* History and/or current positive inhibitor test defined as ≥0.6 BU/mL.
* Treatment with NSAIDs above the maximum dose specified in the prescribing information within 2 weeks prior to screening.
* Systematic treatment within 12 weeks prior to screening with chemotherapy and/or other immunosuppressive drugs.
* Treatment with an investigational product within 30 days or 5.5 half-lives prior to screening, whichever is longer.
* Major surgery within 12 weeks prior to screening or planned major orthopaedic surgery to occur during the study.
* At baseline visit, patients who have not been compliant in using the activity tracker.
Compliance With Gluten-Free Diet and Affecting Factors in Adolescents With Celiac Disease

Celiac is a chronic autoimmune disease that is treated with a gluten-free diet. Adolescents with celiac disease were affected differently by the restrictions during the COVID-19 pandemic. The aim of this study was to determine the compliance with a gluten-free diet during in adolescents with celiac disease during the Covid-19 pandemic and identify the associated factors.

The sample of this study consisted of 85 adolescents in the 10-19 age group diagnosed with celiac disease. Research data were collected by online questionnaires (Google Forms) between January and April 2022. Sociodemographic and disease-related data of adolescents who were compliant and those who were non-compliant with a gluten-free diet during the COVID-19 pandemic were compared.


Eligibility Criteria:
Inclusion Criteria:

* Being in the 10-19 age group,
* Being diagnosed with celiac disease according to the revised ESPGHAN criteria,
* Following a gluten-free diet for at least 6 months before the COVID-19 lockdown,
* Consenting to participate in the study by the adolescents and their parents.

Exclusion Criteria:

-Having any cognitive or mental disorders.
Transbucal Dexmedetomidine for Prevention of Sevoflurane Emergence Agitation in Pre-school Children

The aim of this study is to evaluate the efficacy of transbucal dexmedetomidine given in preschool children undergoing tonsillectomy operations in the prevention sevoflurane agitation.

Agitation during the emergence from general anesthesia is a great post-operative problem that often injures the patients themselves and requires the medical staff to restrain and calm them. The predisposing factors for emergence agitation include anesthesia, operation, and patient. Sevoflurane anesthesia results in higher incidence of emergence agitation than halothane, because of the rapid emergence, and its effects on central nervous system inducing convulsion and post-operative behavioral changes. The otorhinolaryngologic and ophthalmologic surgeries, post-operative pain, young age, pre-operative anxiety, no past surgical history, and adjustment disorder of patients are risk factors.

Dexmedetomidine (DEX), a selective α (2)-adrenoreceptor agonist. Intravenous DEX used after induction of anesthesia reduced sevoflurane-associated EA and postoperative pain in pediatric ambulatory surgery.

The investigators designed this study to prove the efficacy of oral dexmedetomidine a selective α (2)-adrenoreceptor agonist, on emergence agitation (EA), recovery profiles, and parents' satisfaction after sevoflurane anesthesia in tonsillectomy.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II patients
* aged 2-6 years
* patient scheduled for elective tonsillectomy due to recurrent
* chronic tonsillitis

Exclusion Criteria:

* patients with known hypersensitivity to medication drugs
* coagulation disorders
* thrombocytopenia
* significant cardiac
* renal
* pulmonary
* hepatic disease
Menstrual Health and Genital Hygiene Status in Cerebral Palsy

There is little information about the menstrual health and genital hygiene behaviors of young women with CP. The most important reason for this is that women with CP did not meet the inclusion criteria and were excluded from the study. This may lead to a knowledge gap that limits the design of approaches that can help women and families with CP. Therefore, this study was planned to determine menstrual health and genital hygiene behaviors in women with CP.


Eligibility Criteria:
Inclusion Criteria:

for women with cerebral palsy (CP)

1. Participating in the research voluntarily,
2. Being diagnosed with CP
3. To be GMFCS level I-II-II
4. to be 10-30 years old,
5. Being able to read and write Turkish,
6. Not having any mental problems that prevent cooperation and understanding,
7. Being a woman
8. To have menstruated at least once.

For healthy women

1. Participating in the research voluntarily,
2. to be 10-30 years old,
3. Being able to read and write Turkish,
4. Not having any mental problems that prevent cooperation and understanding,
5. Being a woman
6. To have menstruated at least once.

Exclusion Criteria:

1. Having a history of pregnancy
2. Having an acute genital infection
3. To have undergone gynecological surgery.
Effect of FMD on Colorectal Cancer Patients

Extensive preclinical evidence suggests that short-term fasting and fasting mimicking diets (FMDs) can protect healthy cells and render cancer cells more vulnerable to chemotherapy and other therapies. However, fasting is difficult for the old and frail subjects.Therefore, FMDs may be more suitable for postoperative dietary intervention in cancer patients. Colorectal tumors have high glucose consumption, which makes tumor cells very sensitive to changes in nutritional metabolism of the surrounding environment (such as diet restriction / fasting). Previous studies have shown that cyclic FMDs are safe and feasible for cancer patients receiving chemotherapy alone. However, the effects of the FMD in patients under radical surgery for colorectal cancer have not been evaluated so far. This study aims to evaluate the impact of FMDs on postoperative recovery and outcomes of patients with colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 \~ 80 years old
2. Patients undergoing radical colorectal cancer resection for the first time
3. Preoperative clinical tumor stage III
4. ASA grade I-III grade
5. With BMI 19-32 kg/m2
6. Adequate liver function, adequate renal function and normal cardiac function
7. Willing to participate in the research of the subject and agree to follow up regularly

Exclusion Criteria:

1. Evidence of distant metastasis before surgery
2. Before surgery, have received treatment of neoadjuvant chemotherapy
3. Type 1 diabetes or intensive insulin therapy
4. Allergies for FMD content
5. Combined with severe primary diseases such as severe immune system or autoimmune system or long-term using of glucocorticoids or immunosuppressant
6. History of opioid abuse, mental illness or cognitive impairment
Dysregulated CNS Inflammation After Acute Brain Injury

By doing this study, the investigator hopes to learn how the levels of important proteins involved in inflammation change over time in patients with acute brain injury. The total amount of time participants will be asked to volunteer for this study is approximately two hours over a five day period.

This pilot project is a prospective, observational study in 20 patients who are admitted to University of Kentucky (UK) Chandler Medical Center with a diagnosis of severe, non-penetrating traumatic brain injury (TBI) or aneurysmal subarachnoid hemorrhage (aSAH).

All adult participants with a primary diagnosis of severe, non-penetrating TBI or aSAH who are admitted to the neuroscience or trauma intensive care units will be screened for potential inclusion into this study. Once a potential participant is identified, the legally-authorized representative will be approached for study consent and HIPAA authorization. If the participant regains consent capacity before the end of the cerebrospinal fluid (CSF) collection period, assent will be obtained from the research participant.

In this research study, up to 5 small samples of CSF, will be carefully removed from the device, already in place, that drains excess CSF from the participant's head. The samples will be less than 1 teaspoon (\< 5 mL) each. These samples will be frozen and stored until samples from approximately 20 participants have been obtained.

These samples will then be prepared and sent to a research laboratory to analyze the proteins in the samples collected from each research participant.

Because the results of this study will not affect the treatment participants receive in or outside of the hospital, the investigator will not share the results of this study with the participant, their doctor or their family member(s).

Eligibility Criteria:
Inclusion Criteria:

* severe, non-penetrating TBI or aSAH
* must have a ventriculostomy (EVD) placed by the UK Neurosurgery service within 12 hours of primary traumatic episode

Exclusion Criteria:

* non-survivable brain injury or other organ system injury
* life expectancy is five days or less
* penetrating TBI
* status epilepticus upon arrival to the hospital
* severe ischemic heart disease or congestive heart failure, myocardial infarction, or spinal cord injury
* Takotsubo cardiomyopathy secondary to the SAH
* active cancer or have been treated for cancer within the previous 6 months
Parental Involvement and Children's Extra-Familial Contexts

Parental involvement has been shown to be a robust predictor of child conduct problems (CP) and drug use risk in childhood and adolescence, but relatively little attention has been paid to the role of parental involvement in relation to child problem behavior during the transition to school-age, when children are spending more time in school, after-care settings, and in the neighborhood. Concomitantly, as children transition from preschool to school-age, there is evidence to suggest that the quality and organization of schools, after-school care, and neighborhoods play an increasingly important role in the emergence of children's CP and drug use risk. Specifically, we will address: 1) the extent to which the quality of school environments, after-school care, and neighborhoods are associated with the emergence of CP during the early school-age period; 2) how parental involvement in the toddler and preschool period may be associated with parental involvement and monitoring in extra-familial contexts in the early school-age years; 3) how parental involvement in schools, after-care, and the neighborhood, may moderate relationships between extra-familial factors and children's CP; and 4) whether a parenting intervention can increase parental involvement in school, after-care, and neighborhood contexts and decrease risk of children's subsequent CP. These issues will be tested with an existing sample of 731 ethnically-diverse children from urban, suburban, and rural sites. As all families in the study were recruited based on the presence of sociodemographic, family, and child risk factors, the cohort of children are at high risk for displaying a persistent trajectory of clinically-meaningful CP and drug use risk. Thus, the study has the potential to fill a much-needed void on associations between extra-familial contexts and risk for early-starting CP and later problem behavior during the early school-age years. Equally critical, the study can provide data on the potential moderating influence of involved parenting, its malleability for families facing multiple adversities, and whether family-based interventions can make a difference for children facing multiple adversities.


Eligibility Criteria:
Inclusion Criteria:

* Previously enrolled sample of 731 children recruited on the basis of prior screening for socioeconomic, family, and child risk factors at age 2

Exclusion Criteria:

* All children and families needed to have a child 2-3 years of age with multiple socioeconomic, family, and child risk factors.
68Ga-PMD22 PET/CT Examination Targeting CLDN18.2

To investigate the ability of the CLDN18.2-targeted 68Ga-PMD22 tracer to detect CLDN18.2 expression in patients with gastric and colorectal cancer and other gastrointestinal tumours.

The 2016 FAST study brought a "new star" target for gastric cancer - CLDN18.2 (claudin 18 splice variant 2,CLDN18.2), which belongs to the CLDN family of tight junction proteins and is involved in the formation of paracellular tight junctions and maintenance of cell polarity. CLDN18.2 is mainly found in the normal gastric mucosa (normal gastric glands, principal cells, mural cells, endocrine cells) where the differentiation cycle is short and renewal is rapid, and in the duodenal panniculocytes, but not in the gastric stem cell region. It is now generally accepted that CLDN18.2 is expressed in normal gastric tissue confined to the tight junctions at the outer base of the gastric mucosal cells, whereas tumours undergo a change in cell polarity during malignant transformation, resulting in widespread exposure of CLDN18.2 to the cell membrane surface. The CLDN18.2 gene is also aberrantly activated and highly specific and stably expressed in specific tumour tissues, participating in the proliferation, differentiation and migration of tumour cells, making it a potentially effective target for anti-tumour drugs.

In this study, a molecular probe PMD22 targeting CLDN18.2 was synthesised in a previous study and a 68Ga-PMD22 injection was developed for clinical trials. The preliminary study showed that the tracer has good safety and good imaging effect. It is proposed to further conduct exploratory PET/CT imaging studies on patients with gastric cancer, colorectal cancer and other gastrointestinal tumours, to provide a new technique for in vivo, non-invasive and visual detection of CLDN18.2 expression level and spatial distribution for patients with gastric cancer, colorectal cancer and other gastrointestinal tumours, and to validate its clinical application value for the diagnosis of gastric cancer, colorectal cancer and other gastrointestinal tumours.

Eligibility Criteria:
Inclusion Criteria:

* In the near future (within 2 months), patients who plan to undergo puncture biopsy or undergo tumor surgical treatment or are clinically highly suspected of cancer (including primary and tumor recurrence and metastasis)
* Able to understand and voluntarily sign informed consent forms, with good compliance

Exclusion Criteria:

* Severe abnormalities in liver and kidney function
* Suffering from claustrophobia or other mental illnesses
* Pregnant and lactating women
Lung Allograft Rejection Gene Expression Observational (LARGO) Study

The objective of the LARGO Study protocol is to collect peripheral blood samples, select associated lung biopsy pathology slides, and clinical data from lung transplant recipients to perform molecular analyses in association with the study endpoints. The primary objective is to use gene expression profiling of peripheral blood mononuclear cells to differentiate between the absence and presence of acute cellular rejection. The secondary objectives are to use other genomic and proteomic technologies to analyze RNA and protein in blood samples in relation to related clinical conditions. The overall goal is to apply novel molecular insights in the development of non-invasive molecular diagnostic tests for lung transplantation.

LARGO is a prospective, multi-center, international observational study with participating centers in the United States, Canada and Europe. The target enrollment for study completion is 2,100 subjects.

At each study visit, blood specimens are collected from subjects, processed and stored in the sample archive, with corresponding patient information entered into the clinical database. The analysis plan for each study objective includes a defined sample selection protocol that stipulates the inclusion and exclusion criteria for both patients and samples, and also the required number of blood specimens for the molecular analyses to achieve statistical significance.

The diagnosis and treatment of acute cellular rejection remains a clinical management priority that is currently based on transbronchial biopsy. Gene expression profiling is a technology based on molecular biology that measures changes in the RNA levels of different genes expressed by circulating mononuclear cells in the peripheral blood. A key goal of the project is to use gene expression profiling to differentiate between the absence and presence of lung allograft acute cellular rejection, with the aim of using this novel information to develop a non-invasive diagnostic testing alternative.

Eligibility Criteria:
Inclusion Criteria:

* Lung and heart-lung transplant recipients who consent to participate and have transbronchial biopsy at the enrolling center during the study period

Exclusion Criteria:

* None
Potassium Binder in CKD Patients (With Hyperkalemia) (DiPo Trial)

This study hypothesizes that the administration of Sodium zirconium cyclosilicate in CKD patients with hyperkalemia while avoiding dietary potassium restriction will normalize their serum potassium levels. Additionally, we aim to assess the effects of a high potassium diet on renal function, endothelial function, acidosis, systemic inflammatory status and gut microbiota.

A diet rich in fruits and vegetables is associated with better outcomes in CKD patients. However, the presence of hyperkalemia can prevent patients from increasing plant-based foods in their diets. While hyperkalemia can have severe health consequences in advanced CKD, the decreased consumption of plant-based foods can be associated with adverse health outcomes in this population.

Sodium zirconium cyclosilicate (SZC) is a non-absorbed cation exchanger that selectively binds potassium in the intestine.

This study plans to enroll CKD patients with an eGFR ≤45mL/min and a serum potassium ≥ 5mEq/L, administering SZC to achieve normokalemia, and provide them with a diet rich in fruits and vegetables. Endothelial function, inflammatory biomarkers and stool microbiota will be measured to assess the potential benefits of providing a diet rich in fruits and vegetables, albeit rich in potassium, in advanced CKD patients. Because these patients are usually restricting the intake of plant-based proteins and foods due to the concerns of hyperkalemia, eliminating this serious and potentially-life threatening clinical condition might carry health benefits, such as improved endothelial function and decreased inflammation

Eligibility Criteria:
Inclusion Criteria:

* Men and women over the age of 18
* CKD stage 3-4 with an estimated GFR less or equal to 45 mL/min but greater than 15 mL/min
* Serum potassium level ≥5 mEq/L on two blood tests in the past 3 months but less than 6.5mEq/L

Exclusion Criteria:

* On dialysis
* Have been on SZC in the past 3 months
* Reside in a nursing home
* Pregnant patients
* Patients with known cognitive disability
* History of bowel disease such as but not limited to short bowel syndrome, bowel obstruction, inflammatory bowel disease
Safty and Feasibility Study of Therapeutic Cooling in Acute Ischemic Stroke (COOLAID Øresund)

This study is designed to investigate the safty and feasibility of therapeutic hypothermia in acute stroke patients. Soon after arrival in the stroke unit patients are randomized to either hypothermia in the intensive care unit (ICU) or standard treatment in the stroke ward.

Patients randomized to therapeutic hypothermia are analgo-sedated and cooled to at temperature of 33 degrees for a period of 24 hours.

Ischemic stroke remains a diagnosis with limited treatment opportunities and a treatment with the ability to target patients outside the normal treatment window is wanted.

Therapeutic hypothermia (TH) treatment has long been recognised as a treatment of patients with global ischemia following caridac arrest.

This trial is designed to address the safty and feasibility of TH in acute stroke patients.

Patients arriving in our stroke ward are observed for 3 hours. Only non-remitting patients are allowed into the trial.

Patients are randomized to either therapeutic hypothermia with endovascular catheter + nasopharyngeal induction or endovascular catheter alone in the intensive care unit (ICU) (in Copenhagen, Denmark) or intravenous cold saline infusion followed by surface cooling (in Malmø, Sweden)versus standard treatment in a stoke unit.

Patients brought to the ICU are sedated and mechanically ventilated.

Therapeutic hypothermia is induced with a endovascular catether and a nasopharyngeal catheter. Body temperature is lowered to 33 degrees and sustained for a period of 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* National Institute of Health Stroke Scale (NIHSS) score on admission between 5 and 18
* Inclusion within 24 hours after stroke onset
* Diagnosis of ischemic stroke verified by MRI, CT or CTP adjudicated by including physician
* Informed consent from patient or proxy

Exclusion Criteria:

* Modified ranking scale (mRS)\>2 indicating significant disability before onset of stroke
* MRI or CT evidence for massive ischemic damage (\>50% Middle cerebral artery (MCA) territory)
* Severe concomitant diseases such as heart failure, chronic obstructive lung disease or known cancer
* Presently on anticoagulation treatment
* No informed consent from patient or proxy