cyrilzakka/clinical-trials huggingface dataset:
The Effect of Stress Ball Utilisation on Treatment Duration, Dyspnea Severity and Anxiety Level in Nebuliser Therapy

Nebul Therapy is very effective in quickly improving the symptoms of respiratory system diseases. While applying this treatment, patients are expected to complete a sufficient period of time. However, this waiting and the symptoms of the disease may cause anxiety in the patient.

The aim of the study was to enable patients to spend their nebul period actively by using a stress ball. Thus, it was thought that it would make a positive contribution to dyspnea severity and anxiety levels.

The main questions it aims to answer are:

Does using a stress ball contribute positively to nebulizer usage time? Is the use of a stress ball effective in reducing the severity of dyspnea? Is using a stress ball effective in reducing anxiety levels?

For this purpose, participants will be asked to tighten and loosen the stress ball with one hand during the nebuliser therapy.

They will be expected to continue this with at least two nebuliser therapy per day. A control group will be used to determine the effectiveness of the stress ball. This group will not use a stress ball while receiving nebulizer treatment.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized for at least three days
* Having nebulizer treatment at least twice a day
* Medicines that have the same effect as prescribed (bronchodilators)
* Patients who are required to have at least 4 ml of medication in the reservoir
* Patients who have previous experience of using a nebulizer at home

Exclusion Criteria:

* Those who have severe exacerbation attacks
* People with speech problems
* People who experience severe dyspnea due to heart disease
* Those with high anxiety levels for any reason (death of a relative, etc.)
* Those with muscle or nerve problems in their hands
* Those who did not consent to participate in the study
Early TIPS With Polytetrafluoroethylene (PTFE) Covered Stents for Acute Variceal Bleeding in Patients With Advanced Cirrhosis

The purpose of this study is to determine whether early use of transjugular intrahepatic portosystemic shunt (TIPS) with Polytetrafluoroethylene (PTFE) covered stents is able to prolong the survival in patients with advanced cirrhosis and acute variceal bleeding.


Eligibility Criteria:
Inclusion Criteria:

* History of cirrhosis (clinical or by liver biopsy)
* Admission due to acute bleeding from oesophageal or gastric (GOV1 or GOV2) varices
* Child-Pugh Class C (Child-Pugh score less than or equal to 13) or Child-Pugh class B
* Signed written informed consent

Exclusion Criteria:

* Patients not fulfilling inclusion criteria
* Pregnancy or breast-feeding
* Confirmed hepatocellular carcinoma
* Creatinine greater than 3 mg/dl
* Terminal hepatic failure (Child-Pugh score greater than 13)
* Previous treatment with TIPS or combined pharmacological and endoscopic treatment to prevent rebleeding
* Fundal or ectopic gastric variceal bleeding (IGV1 or IGV2)
* Complete portal vein thrombosis or portal cavernoma
* Congestive heart failure New York Heart Association (NYHA) greater than III or medical history of pulmonary hypertension
* Spontaneous recurrent hepatic encephalopathy
Hemofilter Life Span, ECLS And/or CRRT

The goal of this project to better understand the immune-modulatory effects of continuous renal replacement therapy (CRRT) in neonatal and pediatric patients, particularly those receiving extracorporeal life support (ECLS). Little is known about the effects of CRRT in this particular population and improved knowledge will be useful clinically and may lead to novel therapeutic approaches and improved outcomes for these critically ill patients.

Via collection of serum and ultrafiltrate samples, the invesitgators will examine how hemofilter lifespan alters the filtration of pro- and anti-inflammatory cytokines.

Eligibility Criteria:
Inclusion Criteria:

* Neonatal or pediatric patients receiving ECLS (\>2 kilograms and \>34 weeks gestation)
* CRRT utilized during ECLS course
* For the secondary endpoints comparing CRRT-mediated cytokine filtration in patients receiving ECLS with concurrent CRRT to patients receiving CRRT alone (no ECLS), the investigators will also enroll neonatal and pediatric patients receiving CRRT alone (no ECLS). Patients will be eligible for entry into this study if they meet all of the following criteria:
* Neonatal or pediatric patients receiving CRRT

Exclusion criteria:

-Those patients with inability or unwillingness of legal guardian/representative to give informed consent
A New Abdomen Closure Technology Based on Component Separation: a Prospective Randomized Controlled Trial

At present, open-type abdominal surgery is routine access into the abdomen. Median incision is the common choice with open-type abdominal surgery. Layered abdomen-closing is often used at the end-time of the surgery. There are some common postoperative complications, such as incision pain, surgical site infection, surgical incision dehiscence and incisional hernia. The key to reduce the incidence of postoperative complications depends on safe and reliable technology of abdomen-closing.

It's usually difficult to close the abdomen after the incisional hernia surgery, and the recurrence of incisional hernia is high. But the recurrence fell off observably when component separation technology was applied to abdomen-closing of incisional hernia.

Based on this, we hypothesis that modified-CST applied to abdomen-closing in routine abdominal surgery may improve the quality of wound-healing.

In this prospective single-blind randomized controlled trial, traditional abdomen-closing technology and modified-CST will be used to gastric cancer surgery, and the quality of wound-healing will be evaluated to confirm which kind of abdomen-closing technology better.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>18 years of age
* undergoing gastric cancer surgery
* undergoing abdominal surgery first time
* median upper abdominal incision applied (length of incision \> 5cm)
* randomly select abdominal closure technique agreed by patients and family members

Exclusion Criteria:

* women who pregnant
* coagulation disorders
* undergoing immunological therapy
* undergoing chemothearphy within 2 weeks before the surgery
* undergoing Abdominal radiotherapy within 8 weeks before the surgery
* spirit disease patients
* the expecting life span less than 48 hours
* no guarantees to follow-up for 3 years
* patients with poor compliance
Longitudinal Studies of the Glycoproteinoses

The glycoproteinoses are among the most rare and least researched of the lysosomal diseases. The diseases include aspartylglucosaminuria, fucosidosis, galactosialidosis, alpha-mannosidosis, beta-mannosidosis, mucolipidosis II, mucolipidosis III, Schindler disease, and sialidosis. Longitudinal studies of these conditions are needed in order to better define how common the diseases are, identify clinical features which could contribute to early diagnoses, detail progression of the diseases, assess the supportive therapies currently used, and identify potential treatments. Laboratory tests will evaluate metabolic and genetic defects found in participants' blood and urine samples.

This is a longitudinal study of 100 individuals diagnosed with any one of the nine glycoproteinoses. Because of the small number of individuals diagnosed with these diseases, participants will be strongly encouraged to be evaluated in person at a study site, but inability to travel to a study site will not exclude a person from participating. This non-interventional study will also collect medical information about participants through questionnaire, phone interviews, and review of medical records regarding the person's usual medical care, including lab testing and x-rays or other imaging studies.

Participants who are evaluated at the study center will have a physical examination performed by a clinical geneticist and neuropsychological studies administered by the study psychologist. Neuropsychological studies assess intelligence, learning abilities, language skills, and ability to participate in day to day activities of life. Participants seen at the study center will have skeletal x-rays performed to evaluate the impact of the disease on the participant's bones.

Every participant will complete (or have a care provider complete for them)

* A questionnaire about their birth, development, and medical history
* An interview with study personnel (in person or via telephone)
* Follow up interviews on at least an annual basis to update the medical history

Each participant will be asked to

* Give a blood sample
* Give a urine sample
* Some participants may be asked to give a skin biopsy.

Eligibility Criteria:
Inclusion Criteria:

Be an individual of any age diagnosed with one of the following conditions

* Aspartylglucosaminuria
* Fucosidosis
* Galactosialidosis
* alpha mannosidosis
* beta mannosidosis
* Mucolipidosis II
* Mucolipidosis III
* Schindler disease
* Sialidosis

Exclusion Criteria:

* not diagnosed with one of the nine glycoproteinoses listed above.
Preventing Brain Injury in Infants With Congenital Heart Disease

Newborn babies with congenital heart disease often require surgery in the first month of life. The risks of brain damage from congenital heart disease and from the various corrective surgeries are high because of poor levels of oxygen reaching the brain. Topiramate is an anti-convulsant medication that protects brain cells from damage due to low amounts of oxygen in animal studies. The investigators hypothesize that giving topiramate to babies with congenital heart disease before and after surgery will decrease the amount of brain damage caused by the heart disease and/or the surgery to correct the heart disease.

Infants with cyanotic congenital heart disease undergoing surgery in the neonatal period have a high rate of brain injury resulting in seizures, stroke, cerebral palsy, and neurodevelopmental delays. Neuroimaging abnormalities are found in 30% to 60% of cases and neurodevelopmental impairments occur in more than half of these children. The mechanisms of brain injury in these children are not fully understood. Experimental animal models have shown that the abundant release of glutamate in the brain during hypoxic-ischemic insult results in brain injury. Blocking glutamate receptors by administration of the anticonvulsant topiramate has been shown to prevent such injury in animal studies. This study is an open pilot trial of peri-operative topiramate administration to infants with cyanotic congenital heart disease to test the feasibility of this approach and generate preliminary data about markers of brain injury (serum S100B levels and urine metabolomics) and neurodevelopment at 18 months of age. If the approach is feasible and the preliminary data are encouraging a larger efficacy trial will be designed. Although topiramate has been used in neonates and infants to treat seizures and in a pilot study in term infants with hypoxic-ischemic encephalopathy, this is the first study of its effects on markers of brain injury and neurologic outcomes in infants with cyanotic congenital heart disease.

Eligibility Criteria:
Inclusion Criteria:

* Age less than 2 months
* Cyanotic congenital heart disease requiring surgery

Exclusion Criteria:

* Genetic syndromes with high risk of neurodevelopmental delay
* Gestational age less than 35 weeks at birth
* Multiple organ failure or multiple organ anomalies
The Knowledge Gaps of Amputee Rehabilitation Course Content in Physiotherapy Curriculum

Understanding the knowledge gaps of amputee rehabilitation course content is essential for addressing these gaps. Identifying the course contents according to International Classification of Functioning, Disability and Health (ICF) can be a starting point for determining the gaps. This study aimed to investigate which amputee-specific ICF categories are underemphasized in the course content.

For understanding the knowledge gaps of amputee rehabilitation course content, a total of 59 amputee-specific ICF categories were asked to the academics whether these categories are present in the amputee rehabilitation course content. Academics were asked to answer "yes" or "no" to each question. Cochrane Q test was used to test for differences between the frequencies of ICF categories.

Sleep functions, high-level cognitive functions in the field of body functions, writing and handling stress in the activity sub-domain, most of the categories in the participation sub-domain and environmental factors were significantly underemphasized in the course content.This study identifies the knowledge gaps of amputee rehabilitation course content in physiotherapy curriculum.

Eligibility Criteria:
Inclusion Criteria:

* Academicians who continued to teach amputee rehabilitation in different higher education institutions in Turkey were included in the study.

Exclusion Criteria:

* Individuals who did not teach the whole course but contributed to only a part of it were not included in the study
TOtal tRansfemoral branCHed endovasCular tHoracoabdominal Aortic Repair Registry

The purpose of the registry is to evaluate the peri-operative, short-, and mid- outcomes of endovascular treatment of thoracoabdominal aneurysms with multibranched endografts via total transfemoral approach for visceral vessels cannulation using steerable sheaths


Eligibility Criteria:
Inclusion Criteria:

* patient adult ( ≥18 years) of either sex,
* patients who underwent a complex aortic procedure requiring a branched endograft via total transfemoral approach in the centers involved in the TORCH2 Registry

Exclusion Criteria:

* patients who did not receive treatment via total transfemoral approach,
* patient with bleeding diathesis or coagulopathy,
* patients with active systemic or cutaneous infection or inflammation,
* patients who are pregnant or lactating,
* patient younger than 18 years of age.
* Absence of at least one imaging follow-up within the first post-operative year
Applying Artificial Intelligence in Developing Personalized and Sustainable Healthcare for Spinal Disorders

The primary objective is to use machine learning methods on large survey and health register data to identify participants with different treatment trajectories and health outcomes after surgical and/or conservative treatment for spinal disorders.

Secondary objectives are to 1) conduct external validation of the prediction models, and 2) explore how the prediction models can be implemented into AI-based clinical co-decision tools and interventions.

Three work packages are conducted. In the first, the investigators will use data from three general population surveys in Norway (HUNT, Tromsø, and Ullensaker) linked to administrative health registry data (Norwegian Patient Registry (for secondary care) and Norwegian Registry for Primary Health Care) and clinical registers on spinal disorders (the Norwegian registry for spine surgery, NorSpine, and the Norwegian registry for neck and back pain) to explore treatment trajectories and health outcomes following an episode of back and/or neck pain. The investigators will use different combinations of these data sets to assess the impact of a wide range of risk/ prognostic factors and to develop prognostic models for different health and welfare outcomes.

Four major outcomes will be adressed; a) unfavourable outcomes, b) use of prescribed medication, c) use of sickness absence and other disability benefits, and d) patient-reported outcomes.

In the second work package, the investigators will conduct external validation studies of the prediction models by using Danish and Swedish data. There is a large overlap and similarities in health and welfare registers across the Nordic countries.

In the third work package the investigators will first conduct a feasibility study in a secondary care hospital setting in which surgeons examine and assess referred patients with disc herniation and spinal stenosis for surgical treatment (or not). Qualitative interviews will be used to gain a better understanding of today's clinical decision-making process.

Eligibility Criteria:
Inclusion Criteria: patients referred to secondary care for assessment of surgery or not due to disc herniation (lumbar or cervical).

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Exclusion Criteria: ambulant cases who needs immediate treatment

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Observational Study on the Incorporation of Opioids and Their Metabolites Into Hair of Pediatric Patients

Hair analysis is a well-established and important tool in both forensic and clinical context. When it comes to the interpretation of positive hair analysis results, reliable and comprehensive reference data is essential. Such data on opioids, especially novel synthetic ones (such as fentanyl and its analogues (fentalogs)) is currently highly limited. This applies especially to hair with pediatric origin, due to differences in the metabolism and hair anatomy in children compared to adults.

Investigators hypothesize that opioids, both traditional and novel synthetic ones exhibit detectable concentrations and distinct metabolite ratios within the hair matrices of pediatric patients. Thus, this observational, prospective research study provides 150 hair and sweat samples from children who received opioids as part of surgery or pain management. The samples will be consecutively extracted and analyzed using a sensitive targeted liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, enabling the quantitative determination of the opioid and metabolite concentrations. The study thereby contributes valuable reference data for both forensic and clinical applications, addressing challenges in interpreting hair analysis results in especially pediatric populations. Further, a deeper understanding of the mechanisms (e.g. via sweat) and pharmacokinetic processes involved in the opioid incorporation to hair will be achieved. The study has received ethical approval from the Swiss Ethics Board (approval number: 2022-01693 / amendment approval date: 09.01.2024).


Eligibility Criteria:
Inclusion Criteria:

* Obtained written informed-consent from legal representatives (and oral consent from the patient).
* Patient's age must be within date of birth irrespective of gestational age to completed 13th year of life
* Patients that received single or multiple treatment (either with single doses or continuous infusion) of fentanyl, remifentanil or sufentanil either during surgery or during stay in the pediatric intensive care unit

Exclusion Criteria:

* Patient's age of 14 or older
* Inability to understand the study procedure due to language or cognitive reasons (applies to legal representatives and elder children)
* Denied or missing informed consent
* Insufficient amount of head hair to obtain hair sample
* Cosmetic hair treatment, like coloring, bleaching and dying
The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains(Sabin IPV)

Based on pre-clinical trial and phase 1 and phase 2 clinical data and principle of GCP, the objective of phase Ⅲ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).

The Sabin IPV was manufactured with poliovirus type 1, 2, 3 Sabin strains and Vero cells by microcarrier culture in 550 liter bioreactors. The virus suspension was harvested, ultra-concentrated, purified and inactivated with formalin. The D Ag contents of Sabin IPV were type 1 30DU, type 2 32DU, type 3 45DU /0.5ml/per dose.

Inactivated Poliomyelitis Vaccine (Salk strains) was manufactured by Sanofi Pasteur D Ag contents /0.5ml/per dose were type 1 40DU, type 2 8DU, type 3 32DU.

This is a randomized, blind phase 3 clinical trial. Total 1200 infants (ages 60 days to 90 days) were selected, randomized to two groups (Sabin IPV and Salk IPV, each group n=600), infants in each group will be vaccinated with three doses of either Sabin IPV or Salk IPV respectively, one month apart.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, age from 60 days to 90 days;
* Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
* Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
* Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days;
* Axillary temperature ≤37℃.

Exclusion Criteria:

* Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy;
* Low platelet or bleeding disorder do not allow vaccination into the muscle;
* Have damaged or lower immunological function;
* Received blood, plasma or immunoglobulin treatment since birth;
* Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
* Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.

Exclusion Criteria for doses 2 and 3

* Have serious anaphylaxis or high fever, convulsion during first dose;
* Have any circus of Exclusion Criteria after Eligible for study;
* Have serious adverse event which related to previous vaccination; Withdrawal and Discontinuance Criteria;
* Received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents;
* Vaccinated with any other vaccine（except DTP）;
* Stop observation determined by investigator owing to occurring serious adverse event.
Efficacy and Safety of Subsequent Cisplatin and Docetaxel in Ovarian Cancer

The purpose of this study is to assess the efficacy and the safety of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically/cytologically confirmed, optimally debulked stage III-IV epithelial ovarian cancer excluding clear cell histology.
* ECOG Performance Status is 0-2
* No prior chemotherapy for this malignancy,
* Acceptable hematological profile (as defined by a leukocyte count ≥ 3000/mm3, a platelet count ≥ 100.000mm3 and Hb ≥ 9g/100mL), and adequate renal function (as defined by serum creatinine ≤ 1.5mg/dl or creatinine clearance by formulation ≥ 60 mL/min), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value even with hepatic metastasis; transaminases (ALT, AST) ≤ 1.5 x maximum normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone metastasis)

Exclusion Criteria:

* Concomitant use of another anti-cancer therapy
* Unstable medical condition that makes the patient unable to take part in a clinical study (congestive heart failure, serious arrythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 3 months, massive pleural, peritoneal or pericardial effusion; or presence of serious uncontrolled infection.
* Presence of other tumours different from basal cell carcinoma of the skin.
* Pregnancy or breastfeeding. In women of childbearing potential and in men, an adequate contraceptive method must be used
* Social or psychological condition that render the patient inadequate for the follow-up of the study
* Contraindication for any of the study drugs (e.g. history of hypersensitivity to any of the ingredients of the study drugs)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.