cyrilzakka/clinical-trials huggingface dataset:
Intraperitoneal Aerosol Chemotherapy in Gastric Cancer

A prospective series of patients with recurrent gastric cancer will be treated with three cycles of chemotherapy (doxorubicin and cisplatin) instilled into the abdominal cavity in the form of an aerosol under pressure via laparoscopy. The efficacy of this treatment will be assessed by computed tomography, tumor marker studies, and survival. Also, the safety of the procedure will be assessed.

Objectives: To evaluate the safety and efficacy in terms of the clinical benefit rate (CBR) of PIPAC in peritoneal carcinomatosis (PC) from gastric cancer (GC) Study design: Single center, open label, non-randomized, single-arm, repeated single dose study to explore the efficacy, safety, and CBR of doxorubicin and cisplatin when given as a pressurized intraperitoneal aerosol chemotherapy (PIPAC) to patients with advanced gastric cancer and peritoneal carcinomatosis.

Target subject population:Patients with GC and PC with disease progression after at least one line of previous i.v. chemotherapy.

Investigational product, dosage and mode of administration Doxorubicin 1.5 mg/m2 body surface in 50 ml NaCl 0,9% and Cisplatin 7.5 mg/m2 in 50 ml NaCl 0,9% q 4-6 weeks, applied intraperitoneally as PIPAC.

Duration of treatment: 3 single doses in 6 weeks intervals, duration of treatment is 18 weeks

Outcome variables:

1.1 Primary outcome variable • Clinical Benefit Rate (CBR) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1) after 3 cycles of PIPAC with cisplatin and doxorubicin.

1.2 Secondary outcome variables

* The observed survival (OS)
* The median time to progression (TTP) according to RECIST criteria after three cycles of PIPAC with cisplatin and doxorubicin
* The Peritoneal Carcinomatosis Index (PCI) before and after therapy
* The degree of histological regression assessed by pathological review
* Apoptosis as assessed by immunohistochemical analysis
* The difference in ascites volume before and after the first, second, and third PIPAC application 1.3 Patient reported outcomes (PROs)
* European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30, German version ) 1.4 Safety
* Safety and tolerability will be assessed by collection of adverse events, according to the Common Terminology Criteria for Adverse Events (CTCAE) including physical examination results, laboratory assessments (chemistry and hematology).

1.5 Biological monitoring

• Basic research investigating expression of genes associated with drug resistance.

Eligibility Criteria:
Inclusion Criteria:

* age above 18 years
* written, informed consent
* presence of peritoneal carcinomatosis

Exclusion Criteria:

* language barrier
* parenchymal metastases
* unability to undergo laparoscopy
The Effect of Family-Integrated Care Model on Infant and Toddler Health Promotion

The FIC model effectively promotes infant growth, improves nutrition, reduces disease risk, and supports early cognitive and psychological development while enhancing parental caregiving skills, demonstrating strong clinical value.

This study explored the effects of the family-integrated care (FIC) model on growth, nutrition, disease incidence, and early cognitive and psychological development in infants aged 6-18 months. A total of 158 full-term infants were randomly assigned to an intervention group (n=79) or a control group (n=79). The control group received routine health guidance, while the intervention group received additional FIC-based care, including individualized health plans, education, daily care guidance, dietary recommendations, micronutrient supplementation, early intervention, growth monitoring, and vaccination support. Outcomes assessed at baseline and six months post-intervention included growth indices (weight, height, head circumference), nutritional markers (hemoglobin, vitamin D), disease incidence (respiratory infections, gastrointestinal dysfunction, eczema), and Bayley Scales of Infant Development scores. Parental adherence, satisfaction, and caregiving competency were also evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Infants born in our hospital who undergo regular check-ups in the pediatric healthcare department.
2. Age between 6 and 18 months.
3. Complete and comprehensive clinical data.
4. Full-term birth.
5. Families voluntarily participate and sign informed consent.
6. Parents are in good health and have time to accompany their children daily.

Exclusion Criteria:

1. Congenital diseases.
2. Infectious diseases.
3. Familial hereditary diseases.
4. Abnormal conditions during pregnancy or perinatal period.
5. Missing clinical data.
6. No willingness to participate in this study.
7. Abnormal physical or intellectual development of the infant.
8. Intellectual disabilities of the guardians. -
Prize Reinforcement Contingency Management for Cocaine Dependence: a 24-week Randomized Controlled Trial

The purpose of this study is to determine whether prize-based contingency management (prizeCM) combined with cognitive behavioral therapy (CBT) is more effective in the treatment of of cocaine-dependent patients compared to CBT only. Patients were randomized to prizeCM + CBT (experimental group) or to CBT (control group) an treated over 24 weeks. It is the first trial of this type in Europe.


Eligibility Criteria:
Inclusion Criteria:

* cocaine dependence, aged 18 or older, other dependences

Exclusion Criteria:

* severe somatic, brain, or psychiatric disease, attention deficit disorders with medication methylphenidate
Expansion of Umbilical Cord Blood Using a Unique Bio-system

By doing this study, researchers hope to develop a special technique and laboratory conditions to help support umbilical stem cell growth and multiplication.

In this project, researchers propose a three dimensional (3D) microenvironment that mimics the bone marrow stem cell microenvironment, with its supporting cells of osteoblasts and stromal cells. In theory, this will result in better expansion of cord blood stem cells ex vivo.

To successfully expand umbilical cord blood stem cells ex vivo, a microenvironment that resembles the stem cell microenvironment, or stem cell 'niche' should be created. In designing this bio-system, we make use of several observations. First, bone osteoblasts are important in promoting hematopoietic stem cell expansion, accordingly, this bio-system will ensure the physical proximity of the cord blood stem cells to a 3D bone tissue derived from mesenchymal stem cells (MSCs). These MSCs will be isolated from Wharton's jelly, and by using an osteogenic medium and special scaffolds, these MSCs will differentiate into osteogenic progenitors creating a 3D bone structure. The other observation is that, co-culture of cord blood stem cells with mesenchymal stem cells is superior to liquid cultures in terms of ex vivo expansion , accordingly, in this experiment, undifferentiated MSCs will be co-cultured with cord blood stem cells in this created 3D bone structure. This is a unique design that has the potential to expand cord blood stem cells more efficiently.

Eligibility Criteria:
Inclusion Criteria:

* females that consent to permit researchers collect the discarded umbilical cords from the placenta and use for research purposes.

Exclusion Criteria:

-
Perioperative Insulin, GIK or GLP-1 Treatment in Diabetes Mellitus

The incidence of diabetes mellitus type II is increasing. More and more patients who need surgery have diabetes mellitus type II. Despite an enormous amount of glucose lowering protocols and the proven negative effects of hyperglycaemia. There is no evidence for the optimal glucose lowering protocol.

This study investigates the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing intraoperative glucose-insulin-potassium infusion (GIK), insulin bolus regimen (BR) and GLP-1 (liraglutide, LG) treatment.

Diabetes mellitus is associated with poor outcome after surgery. The prevalence of diabetes in hospitalised patients is up to 40%, meaning that the anaesthesiologist will encounter a diabetes patient in the operating room on a daily basis. Multiple protocols for perioperative glucose regulation have been developed, ranging from intravenous glucose-insulin-potassium infusion to subcutaneous bolus regimens. Despite this abundance of published glucose lowering protocols and the proven negative effects of intraoperative hyperglycaemia in diabetes, there is no evidence regarding the optimal intraoperative glucose lowering treatment. Recently, incretins have been introduced to lower blood glucose. The main hormone of the incretin system is glucagon-like peptide-1 (GLP-1). GLP-1 increases insulin and decreases glucagon secretion in a glucose-dependent manner, resulting in low incidence of hypoglycaemia. This study investigates for the first time the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus undergoing non-cardiac surgery.

Objective:

This study investigates the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing intraoperative glucose-insulin-potassium infusion (GIK), insulin bolus regimen (BR) and GLP-1 (liraglutide, LG) treatment.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* known diabetes mellitus type II for \> 3 months
* aged 18-75 years
* scheduled for elective non-cardiac surgery

Exclusion Criteria:

- Daily insulin dosage of \> 1 IU/kg body weight

* Oral corticosteroid use
* Planned for day-care (ambulant) surgery
* Planned ICU stay post-operatively
* Planned bowel surgery
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Impaired renal function defined as serum-creatinine ≥ 133 μmol/L for males and ≥ 115 μmol/L for females
* Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
* Known or suspected allergy to trial product(s) or related products
* Any condition that the local investigator feels would interfere with trial participation or the evaluation of results
Reward and Punishment Sensitivity in Bipolar Disorders

Bipolar disorder (BD) represents a chronic mood disorder and one of the leading causes of disability worldwide. Complexity of its clinical presentations leads to delayed diagnosis and difficult management in routine clinical settings. Whereas distinguishing BD-I and BD-II main subtypes has a significant relevance for treatment strategy and for outcome, there are currently no clinical determinants of the BD subtype which could be used as early diagnostic predictors.

* While neurobiological specificity of each BD subtype is still controversial, available evidence suggest different dopaminergic abnormalities in each subtype. Dopaminergic function is involved in decision making and reward processing which may represent useful BD subtype markers.
* This study aims at assessing decision making during appetitive and punitive reinforcement learning in patients with BD I and BD II subtypes compared to healthy controls


Eligibility Criteria:
Inclusion Criteria:

* bipolar disorder (BD) type I or II, according to DSM (Diagnostic and Statistical Manual)-5 criteria
* Montgomery and Asberg Depression Rating Scale (MADRS) score \< 15
* Young Mania Rating Scale (YMRS) score \< 12

Exclusion Criteria:

* other main diagnosis than bipolar disorder
* other medical condition leading to cognitive deterioration
Preparation and Characterization Intranasal Film Loaded With Steroid as a Local Treatment of Anosmia in Compare to Insulin Intranasal Film

This study is a growing step of phase I study published on March 2021. The study was implicated on Minia university on small scale of patient (20) to investigate the impact of insulin as fast dissolving films for intranasal delivery to treat anosmia in post COVID-19 infections. this record will modify the first formulation by addition certain concentration of steroid.


Eligibility Criteria:
Inclusion Criteria:

* All patients' adults aged from 18 years to 50 will included in the study.
* A confirmed case (positive PCR), recovered/discharged (2 negative PCR),
* suffering from sudden recent anosmia or hyposmia with or without loss of taste.

Exclusion Criteria:

1. Patients with chronic sinusitis.
2. Patients with acute allergic rhinitis.
3. Patients' nasal polyposis
4. Patients with history of nasal surgery, severe head trauma or any medical condition that may affect sense of smell.
5. Patient poly morbidities or poly pharmacy.
6. Elder, pregnant, or nursing woman.
7. Patients with chronic diseases.
8. Autoimmune diseases.
9. Patient suffering end organ problems.
Efficacy of Betalactam Antibiotics in Prolonged Infusion Compared to Intermittent in Pediatric Patients With Sepsis

This study evaluates the efficacy and safety of the administration of betalactam antibiotics in prolonged infusion compared to intermittent infusion in children with sepsis. Half of participants will receive piperacillin/tazobactam, imipenem or meropenem in continuous or extended infusion, while the other half will receive piperacillin/tazobactam, imipenem or meropenem in intermittent infusion.

Sepsis is the leading cause of morbidity and mortality in hospitalised patients globally. Betalactams are time-dependent antibiotics, and so, the duration of time for which the free drug plasma concentration remains above the minimum inhibitory concentration (fT \> MIC) is the pharmacokinetic/pharmacodynamic index associated with bacterial killing and clinical improvement. Numerous studies have demonstrated that continuous infusion (infusion in 24 hours) and extended infusion (through prolonging the infusion time to greater than 3 hours) allows the maintenance of concentrations above the MIC for a longer period of time within the dosing interval (30 minute or 1 hour), and so, capitalises on the pharmacodynamic properties of betalactams and maximises bacterial killing, therefore potentially improving clinical outcomes. In adult patients, the several studies suggest that prolonged infusion may offer clinical benefits and significant reduction in mortality without increasing the risk of toxicity, however, there is limited information about these dosing strategies in pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with sepsis, who have been evaluated by an infectious physician and are candidates to receive piperacillin/tazobactam, imipenem or meropenem as empiric treatment.

Exclusion Criteria:

* Patients with a history of allergy to one or more of the proposed antibiotics.
* Patients with chronic kidney disease or acute renal failure.
* Patients with acute liver failure of any cause.
* Patients in palliative or supportive care only.
Effects of a Psychiatric Intensive Care Unit

The purpose of the study is to compare the effects of using or not using a Psychiatric Intensive Care Unit (PICU) in an acute psychiatric department.

The main aim of the study is to compare the effects of using or not using a Psychiatric Intensive Care Unit (PICU) in an acute psychiatric department.The acute ward of Østmarka psychiatric department, St. Olavs Hospital has a PICU separated from the rest of the ward. The PICU is separated with a locked door. Under two different conditions at different times all patients evaluated to be in need of PICU were admitted to the PICU. In the first condition the doors inside the PICU and between the rest of the acute ward and PICU were closed or locked. In the second condition the doors inside the PICU and the door between the PICU and the rest of the acute ward were either removed or held permanently open. In the second condition the patients thus were admitted to a PICU unit not using PICU principles.

The patients were evaluated with different rating scales at admittance, day three and at discharge from PICU.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to Østmarka psychiatric department, St. Olavs Hospital in need of a PICU.

Exclusion Criteria:

* Patients with dementia or mental retardation to an extensive degree.
* Patients not speaking Norwegian or English.
Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus.

The purpose of this study is the prevention of Staphylococcus aureus pneumonia in mechanically ventilated subjects heavily colonized with S. aureus. Staphylococcus aureus is a human pathogenic bacterium that causes severe infections, including pneumonia and sepsis. Hospital-acquired bacterial pneumonia (HABP) caused by S. aureus, including ventilator-associated bacterial pneumonia (VABP) in mechanically ventilated subjects, is a significant public health threat despite efforts to optimize antibiotic treatment. ASN100 is an investigational monoclonal antibody product that targets the toxins produced by S. aureus to protect subjects from developing S. aureus pneumonia.

This is a double-blind, randomized, single-dose, placebo-controlled study of ASN100 for the prevention of S. aureus pneumonia in mechanically ventilated subjects who are heavily colonized with S. aureus. This will be a global study conducted at approximately 65 sites to assess the safety, tolerability, and efficacy of ASN100.

Eligible subjects who meet all of the inclusion criteria and none of the exclusion criteria will be screened by semi-quantitative culture of an endotracheal aspirate (ETA) to identify those who are heavily colonized with S. aureus (3+ to 4+). Upon determination of eligibility, subjects will be randomized in a 1:1 ratio to 1 of 2 treatment groups, ASN100 or placebo.

Eligibility Criteria:
Inclusion Criteria:

- Subject is currently hospitalized and is mechanically ventilated endotracheally (i.e., orotracheal or nasotracheal) and, in the Investigator's opinion, will require ongoing ventilator support for at least 48 hours;

Exclusion Criteria:

* Subject has a chest X-ray or thoracic computed tomography (CT) scan that is definitive for a diagnosis of pneumonia
* Subject has a known and documented ETA culture showing heavy colonization with a -Gram-negative organism at enrollment or at any time during the Screening period;
* Significant Neutropenia
* Severe non-pulmonary source of infection.
* Subjects with a known history or current (suspected) diagnosis of cytokine release syndrome associated with the administration of peptides, proteins, and/or antibodies.
Periodontitis and Atherosclerotic-related Arterial Stenosis

This study aimed to evaluate the association between periodontitis and atherosclerosis of the cerebral vasculature in the Chinese population.

Periodontitis has been demonstrated as a risk factor for ischaemic stroke in several clinical studies. Atherosclerosis of the cerebral vasculatureis an important pathological process causing ischaemic stroke. The investigator's study aims to investigate the relationship between tooth loss(used as a surrogate of periodontal disease) and atherosclerotic-related arterial stenosis in the Chinese population. An estimated 1,000 participants that underwent cerebral angiography at Guangdong Provincial Hospital of Chinese Medicine between Apirl 2020 and January 2022 will be recruited in this trial. Arterial stenosis features of each participants will be collected based on the results of digital subtraction angiography (DSA). The missing teeth counts of each participant will be collected and some of them will recieved comprehensive periodontal examination. Besides, blood samples will be collected in order to investigate the serum inflammatory markers(CRP,WBC,albumin,IL-6,IL-10). The relationship between tooth loss and atherosclerotic-related arterial stenosis will be analysed by regression models adjusted for conventional risk factors (sex,age, obesity,smoking,Alcohol drinking,diabetes,hypertension,hyperuricaemia,hyperhomocysteinaemia)

Eligibility Criteria:
Inclusion Criteria:

1. subjects who underwent cerebral angiography at Guangdong Provincial Hospital of Chinese Medicine from April 2020 to December 2021
2. subjects who voluntarily participated in this study and provided informed consent.

Exclusion Criteria:

1. intracranial and extracranial artery stenosis caused by vascular inflammation, systemic connective tissue disease, and muscle fibre structure hypoplasia
2. inability to cooperate with the investigation
3. intracranial aneurysm and cerebral arteriovenous malformation confirmed by cerebral angiography
4. receipt of periodontal treatment in the previous 24 months.
The Effect of Balance Training in People With Functional Ankle Instability (FAI)

Ankle sprain is the most occurring sport related injury. In addition, 40% of the people who sustain such an injury display residual symptoms under the general denominator functional ankle instability (FAI). In literature, there is already given a lot of attention to extrinsic and intrinsic risk factors of FAI. Furthermore, there is a major focus on the possible interventions which may be able to reduce the chance of developing chronic instability. At this moment there is a lack of unequivocality.

In this study the investigators address the question of what is the effect of a balance training programme on the movement strategy. Therefore kinematics, kinetics, plantar pressure measurements and muscle activity are taken in consideration The purpose of this study is a better insight in the effect of treatment on the residual symptoms related to FAI.


Eligibility Criteria:
Inclusion Criteria:

* a history of more than 1 unilateral ankle sprain
* presence of feeling of 'giving way'
* a feeling of weakness around the ankle
* a decreased functional participation

Exclusion Criteria:

* ankle fracture
* ankle surgery
* lower limb pain (not related to an ankle sprain)
* ankle distortion in the last 3 months
* currently receiving treatment
* disturbance of equilibrium
A Non-Interventional National Study in Pediatric Patients With Unexplained Enlarged Spleen

Primary Objective:

To assess prevalence of Gaucher disease (GD) diagnosed in pediatric patients presenting with unexplained splenomegaly (SMG) after exclusion of first intention-diagnoses (e.g. portal hypertension, haematological malignancy, hemolytic anemia, infection) based on clinical examination and routine biological tests (full blood count, reticulocytes, liver tests, abdominal ultrasound, Coombs test and Epstein Barr virus serology).

Secondary Objectives:

* To describe the rate of each identified disease category and the rate of patients with no final diagnosis at the end of the study in pediatric patients with unexplained SMG after exclusion of first intention diagnoses
* To describe the characteristics (clinical, lab, genetics) of all pediatric patients included in the study and to describe the characteristics subdivided by identified disease category and absence of final diagnosis at the end of the study

The planned duration of this study is 39 months, which includes 36 months of patient recruitment.

Eligibility Criteria:
Inclusion criteria:

* Patient under the age of 18 years
* Patient with unexplained SMG (SMG defined as a palpable spleen, already known or discovered for the first time) and who has undergone tests to eliminate obvious causes of SMG

Exclusion criteria:

Patient with any obvious cause of SMG as described by clinical examination and/or lab or imaging test available in medical records and/or having been diagnosed with any of the following conditions:

1. hemolytic anemia
2. hematological malignancy
3. portal hypertension
4. infectious disease associated with SMG (Cytomegalovirus, Epstein Barr virus, leishmaniasis or other obvious infectious cause revealed by the medical history)

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