cyrilzakka/clinical-trials huggingface dataset:
Effect of Malnutrition on Liver and Spleen Stiffness in Children

This prospective observational study aims to evaluate the effect of malnutrition on liver and spleen stiffness in children using shear wave elastography. Two groups of participants will be enrolled: children diagnosed with malnutrition and age-matched healthy controls. Organ stiffness measurements will be compared between the two groups to assess the impact of malnutrition on liver and spleen tissue properties.

This is a prospective observational study designed to investigate the effect of malnutrition on liver and spleen stiffness in children. The study will include two groups: children diagnosed with malnutrition according to WHO criteria, and age- and sex-matched healthy controls without any known chronic illness.

All participants will undergo shear wave elastography (SWE) to measure liver and spleen stiffness using standardized ultrasound protocols. Measurements will be performed by a pediatric radiologist blinded to the nutritional status of the participants.

The primary objective is to compare organ stiffness values between malnourished children and healthy controls. Secondary analyses will explore correlations between severity of malnutrition and stiffness values. The study aims to provide non-invasive insights into early organ-level changes associated with pediatric malnutrition.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 to 18 years.
* Diagnosis of malnutrition based on World Health Organization (WHO) criteria (for malnutrition group).
* Healthy children without any chronic illness (for control group).

Exclusion Criteria:

* Children with chronic diseases (e.g., liver disease, diabetes, immunocompromised conditions).
* Children who have previously undergone liver or spleen surgery.
* Children with inability to cooperate during elastography measurement.
PaO2 and Lung Function After Orthopedic Surgery

Hypoxia and reduced oxygen partial pressure is commonly occurring after abdominal surgery. This study aims to investigate whether similar changes also occur after orthopedic surgery in the form of upper limb surgery.

Inclusion: 60 patients undergoing orthopedic surgery in the form o knee-, hip-, shoulder- or elbow surgery.

Exclusion: Dementia or cognitive impairment that makes it impossible to participate in studies.

Arterial blood gas and lung function are undertaken before surgery, the day after surgery and at follow-up.

Postoperative hypoxia complicates 30% - 50% of abdominal surgeries. People at particular risk for postoperative pulmonary complications including severe hypoxia are those who undergo abdominal surgery, emergency surgery or have a respiratory failure due to chronic lung disease including obstructive sleep apnea. The cause of postoperative restrictive lung function and hypoxia is unknown. Previous studies report that PaO2 decreases by an average of 2 kPa after abdominal surgery, while PaCO2 is unchanged and vital capacity decreases by 35%. The effect of orthopedic surgery on oxygen and carbon dioxide partial pressure and lung function has previously not been investigated. This study aims to investigate possible changes in oxygen partial pressure and vital capacity after orthopedic surgery.

Design: Prospective cohort study

Inclusion: 60 patients undergoing orthopedic surgery in the form o knee-, hip-, shoulder- or elbow surgery..

Exclusion: Dementia or cognitive impairment that makes it impossible to participate in studies.

Method: Blood gas measurements and Lung function (Vital capacity and FEV1) The day before surgery, the day after surgery and at follow-up.

Power analysis: There is a need to investigate 34 patients if the mean (SD) difference is 1 (2) kPa. Due to drop-outs the investigators calculate a need to include 60 patients.

Primary outcome measures:

• PaO2 from atrial blood gas

Secondary outcomes

* Vital capacity
* PaCO2 from atrial blood gas
* Forced expiratory volume in one second (FEV1)

Other variables examined: age, sex, height, weight, type of surgery, type of anesthesia, smoking status, length of surgery and previous diseases

Eligibility Criteria:
Inclusion Criteria: Patients undergoing shoulder or elbow surgery -

Exclusion Criteria: Dementia or cognitive impairment that makes it impossible to participate in studies. Not willing to participate

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Optimizing Response to Li Treatment Through Personalized Evaluation of Individuals With Bipolar I Disorder: The R-LiNK Initiative

Bipolar disorder (BD), especially BD type I, is a highly prevalent mental disorder and a is a highly prevalent mental disorder and an important factor for suicide. Lithium is the key treatment for prevention of BD relapse and has a proven suicide prevention effect. Whilst many cases become asymptomatic with lithium treatment, the majority show sub-optimal response.

The objectives of this project are to:

* improve outcomes of bipolar I disorder (BDI) cases prescribed lithium through the application of stratified approaches
* optimize the early prediction of lithium response using a set of multi-modal biomarkers ("blood omics", Magnetic Resonance Imaging and Li7-Magnetic Resonance Spectroscopy derived-markers)
* develop a multidisciplinary multinational network of experts to undertake this and future projects on personalized diagnostics and therapeutics and
* implement new, powerful technologies to characterize brain lithium distribution and the blood molecular signature of lithium in responders and non-responders.

This cutting edge approach will identify the eligibility criteria for treatment with lithium in BD in terms of response, safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Decision to prescribe Li as a prophylactic treatment based on clinicians' assessment
* Confirmed diagnosis of BD1 according to DSM-5 criteria
* Aged 18-70 years.
* Able and willing to give written informed consent
* consents to blood sample for the purpose of the RLiNK study
* Covered by a Social Security Insurance where applicable
* Patients on Curatorship (consent form signed by the patient and specific consent form for the curator)

Exclusion Criteria:

* Trial of Lithium undertaken within the last 6 months
* Lifetime history of mood disorder better explained by a DSM-5 definition for schizoaffective disorder
* Pre-lithium screening suggest that Lithium initiation is contraindicated:
* Incompatible concurrent treatments: long-term use of non- steroidal anti-inflammatory drug or diuretics for a known and established comorbid disorder with no possible alternative treatment (i.e. absolute contra-indication to Li treatment)
* Health issues (risk of worsening of a pre-existing condition) Psoriasis, Brugada syndrome
* Renal dysfunction: Glomerular Filtration rate below 60mL/min/1.73m 2
* On-going Pregnancy or planned pregnancy on the next 2 years
* Lactating and breast feeding women (see SmPc)
* Pregnant women
Safety and Pharmacokinetic Study of OMT-28 in Healthy Subjects

The aim of this first-in-human study is to assess the safety, tolerability, PK and exploratory pharmacodynamics (PD) of single and multiple oral ascending doses of OMT-28 in healthy male subjects to support further clinical development of OMT-28 in the indication of atrial fibrillation (AF) and to obtain data on food and gender effects of OMT-28 to guide dosing for Phase II trials.

This first-in-human study will be carried out in one study center involving multiple steps. Up to 100 healthy male and female subjects will be enrolled. The study consists of 4 parts:

1. a single ascending dose (SAD) part
2. a multiple ascending dose (MAD) part
3. a single dose, double cross-over food effect (FE) part.
4. a single dose gender effect part (female subjects group) The safety and PK data will be evaluated by the DSMC after each cohort to decide on further dose escalation.

Eligibility Criteria:
Inclusion Criteria:

1. In general good physical health as determined by medical and surgical history, physical examination, 12 lead ECG, vital signs, and clinical laboratory tests
2. Normal blood pressure (Systolic Blood Pressure (SBP) between 100 to 140 mmHg (both inclusive); Diastolic Blood Pressure (DBP) ≥55, ≤89 mmHg) measured after 5 min rest in supine position.
3. SAD, MAD, and FE part: male of 18 to 45 years (inclusive) of age.
4. Gender effect part: female of 18 to 45 years (inclusive) of age.

Exclusion Criteria:

1. More than moderate smoker (\> 10 cigarettes/day).
2. More than moderate alcohol consumption (\> 35 g of ethanol regularly per day or \> 245 g regularly per week).
3. Use of any medication
4. One or more key safety laboratory parameters out of normal range Gender effect part Pregnant or breastfeeding women and of childbearing potential Previous assignment to treatment during this study.
Inhibition of Sterile Inflammation by Digoxin

To investigate the effect of digoxin on pyruvate kinase isoform 2 (PKM2) binding to pro-inflammatory loci and innate immune inflammatory responses in the peripheral blood in healthy subjects.

To investigate the effect of orally administered digoxin on innate immune inflammatory responses in the peripheral blood of healthy subjects. We hypothesize the reduction in innate immune inflammatory responses will be expected in the peripheral blood with the effect of oral digoxin.

To investigation how human peripheral blood immune cells change their inflammatory responses after exposure to digoxin in vitro.

Eligibility Criteria:
Inclusion Criteria

1. Age \>18 y ≤ 70 years
2. subjects with normal serum creatinine, normal EKG and currently not taking any medication.

Exclusion criteria

1. Autoimmune liver disease (ANA \> 1/320)
2. Chronic viral hepatitis
3. Hepatocellular carcinoma
4. Complete portal vein thrombosis
5. Extrahepatic terminal disease
6. Pregnancy
7. Treatment with prednisolone or pentoxifyllin for more than 3 days prior to inclusion/start date
8. Active alcohol abuse (\>50 g/day for men and \>40 g/day for women) in the last 3 months
9. AST \> ALT and total bilirubin \> 3 mg/dl in the past 3 months
10. Liver biopsy and/or clinical picture consistent with alcoholic hepatitis
11. Lack of signed informed consent.
12. Known hypersensitivity to digoxin or other forms of digitalis, ventricular fibrillation.
13. Any significant medical conditions, any electrolyte abnormalities, over the counter medications, natural products and prescription drugs.
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

To establish the efficacy of a 20 mg/day dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.

To establish the efficacy of a 20 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1 to 1 ratio to either istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline as compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

1. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
2. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale.
3. On levodopa/carbidopa for at least one year, stable dose in past 4 weeks.
4. Currently take at least three doses of levodopa/carbidopa per day.
5. Predictable end of dose wearing off.
6. Able to satisfactorily complete Hauser version of a Parkinson's diary.
7. Have an average of 180 minutes of OFF time on two 24 hour diaries.
8. Be at least 30 years of age.

Exclusion Criteria:

1. Neurosurgical treatment for PD.
2. History of psychosis.
3. Diagnosis of atypical parkinsonism, secondary parkinsonism variant or Parkinson's plus syndromes.
4. Diagnosis of cancer within 5 years.
5. Mini-mental status examination score of 25 or less.
6. History of seizures or neurologic malignant_syndrome.
7. Clinical depression.
MR-Guided Laser Ablation of Hepatic Tumors

This is a pilot study to investigate the performance of MR-guided Laser Induced Thermal Therapy (LITT) in the treatment of liver tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with soft tissue tumor metastases to the liver who are referred to Interventional Radiology for treatment.
* Surgery is not a viable or desirable alternative therapy at the time of enrollment
* Radiation therapy has failed or not indicated or can be safely postponed
* Tumor size ≤ 5 cm at its largest diameter
* Tumor position is not in the central liver hilum
* Performance status is ECOG 2 or better in adults
* Patient is able to undergo MRI

Exclusion Criteria:

* Patients with pacemaker or defibrillator
* Patients with metallic surgical clips close to the site of the intended ablation
* Pregnant women
* Patients with hilar liver lesions
Clinical Evaluation of a Bioactive Material

The clinical performance of a bioactive composite and a posterior resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a bioactive composite \[Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)\] and a posterior resin composite \[G-ænial Posterior (GC, Tokyo, Japan) (GP)\] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.


Eligibility Criteria:
Inclusion Criteria:

* age range will be 18 to 65
* patients should have at least 2 approximal caries lesions require restoration
* healthy periodontal status
* a good likelihood of recall availability

Exclusion Criteria:

* poor gingival health
* adverse medical history
* potential behavioral problems
Impact of Patient Reported Outcomes for Pre-chemotherapy Medical Decision in Day Patients With Digestive Cancer

The investigators hypothesize that an early assessment of the clinical toxicity of the patient is possible via patient reported outcomes and that this information provides at least the same information level as the clinical examination of the patient made by the doctor. The early decision to prepare chemotherapy medications based on the indirect early collection of clinical information from the patient via a patient reported outcome should help minimize the number of chemotherapy medications destroyed.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* Patient is undergoing at least their second chemotherapy regime (outside weekly scheme or protocol with cisplatin requiring hospitalization) for a digestive tumor
* Patient has a Smartphone or access to the internet (via tablet or computer)
* The patient is under consultation as a day patient in the Oncology Department of Nimes hosptial

Exclusion Criteria:

* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant, parturient or breastfeeding
* Patient has already participated in the study
* Patient undergoing first chemotherapy regime
Emotion Regulation Training, Nursing Student, and Alexithymia

This study aimed to investigate the effects of emotional regulation training, which is a prepared based on the cognitive behavioral approach, on alexithymia in nursing students.

This study aimed to reduce alexithymia levels in nursing students with emotion regulation training based on a cognitive behavioral approach. The study was conducted with 74 nursing students, 37 in the intervention group and 37 in the control group, studying at a foundation university in the 2023-2024 academic year. The study data were collected using the data collection form and the Toronto Alexithymia Scale-20 (TAS-20). Data collection tools were applied three times as pre-post and follow-up tests. Male and female students who met the inclusion criteria of the study were determined by using the pre-test of the population. For the sample group to represent the population, students with high levels of alexithymia were identified by stratification by determining the class and gender ratios. Then, students were assigned to intervention and control groups by randomization. The 7-session training program prepared for the students in the intervention group was applied. No intervention was made to the control group during the implementation. After the training sessions were completed, post-test data were collected. Follow-up measurements were made three months later.

Eligibility Criteria:
Inclusion Criteria:

* To be a student of the nursing department
* Agree to participate in the study

Exclusion Criteria:

* Having received psychological support within the last 10 years
* Having a psychiatric disorder
* Not being a citizen of the Republic of Turkey
Whether Sputum Can Serve as an Alternative Source for Liquid Biopsy in Patients With Lung Cancer

This study intends to use Onconscreen plus 520 Panel (Burning Rock, China) to conduct NGS testing in sputum, tissues and blood samples of patients with advanced NSCLC. In order to explore the use of sputum as a diagnosis method for NSCLC patients, we will collect relevant clinical information and follow-up treatment information. The primary endpoint will reveal the effectiveness, accuracy, and feasibility in sputum, as compared to tissues and blood samples. This study aims to study the feasibility and advantages/disadvantages of using sputum as an noval body fluid biopsy option.

With the advancements in the development of targeted therapy, the detection of actionable genes has become routine practice in diagnosing lung cancer, especially in non-small cell lung cancer (NSCLC). Due to its non-invasiveness and great accessibility, plasma-based mutation profiling, with a sensitivity of approximately 70% relative to tissue samples, is widely used in clinical settings. Profiling using other body fluids such as pleural effusion, ascites, cerebrospinal fluid have been actively explored. Circulating cell-free DNA has also been shown to be present in other bodily fluids such as sputum and urine, which have potential to serve as liquid biopsy media for comprehensive mutation profiling. In this study, we investigated the potential of sputum obtained from NSCLC patients for mutation profiling using matched tissue, plasma and sputum from more than 30 advanced-stage NSCLC patients.

Baseline tissues, plasma and sputum samples from more than 30 newly diagnosed advanced NSCLC patients with 520 Panel sequencing (tissue 1000X, sputum 1000X, plasma cfDNA 10000X), in different methods will be compared.

Primary endpoints:

1、Compare different sample types with concordence rate, sensitivity, and specificity.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with stage IIIB-IV NSCLC in AJCC TNM stage (8th edition) confirmed with histology or cytology;
2. Newly diagnosed;
3. There are sufficient samples that meet the requirements for examination;
4. Eligible for the next anti-tumor systemic treatment;
5. Willing to sign the consent inform, age ≥18 years;
6. Patients willing to cooperate with the planned follow-up schedule;
7. Permit to collect clinical data needed by the institute.

Exclusion Criteria:

1. Diagnosed with other malignant tumors at the same time (except for fully treated cervical carcinoma in situ, basal or squamous cell skin cancer);
2. The patient has other serious diseases that may affect follow-up and short-term survival;
3. Any other medical conditions and social/psychological problems that investigator evaluated is not suitable to enroll in this study;
4. Absents of contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computer tomography (CT) during clinical follow-up.
Efficacy and Safety of Butorphanol Tartrate Injection for the Patients With Mechanical Ventilation

To compare the incidence of hospital-acquired infections between butorphanol and fentanyl.

Butorphanol can improve inflammation and promote the recovery of pro-inflammatory/anti-inflammatory cytokine balance.However, there is still a lack of relevant clinical studies on butorphanol and fentanyl for the incidence of hospital-acquired infections in ICU mechanically ventilated patients.The objective of this study was to evaluate the analgesic efficacy,safety and the incidence of nosocomial infection of butorphanol in mechanical ventilation patients between butorphanol and fentanyl.

Eligibility Criteria:
Inclusion Criteria:

* need mechanical ventilation for more than 48 hours
* more than 18 years old
* without hospital-acquired infection before admission to ICU
* volunteer to participate in this study

Exclusion Criteria:

* allergic or contraindicated to the drug
* severe cardiac insufficiency, conduction block and bradycardia
* recent use of analgesic, sedative and antidepressant drugs
* psychiatric or neurological diseases or neurosurgery-related diseases
* history of steroid cortisol and immunosuppressants
* severe liver dysfunction or renal dysfunction
* pregnancy
* refuse to enrollment
Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with GLP-1 analogue in patients with type 2 Diabetes for 52 weeks.

This is an open-label study to evaluate the long-term safety and efficacy of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with GLP-1 analogue on diet and exercise and have inadequate glycemic control. The patients will receive TA-7284 100mg orally for 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients who has been receiving a stable dose and regimen of GLP-1 analogue over 12 weeks before administration of investigational dug
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
* Patients with HbA1c of ≥7.0% and \<10.5%
* Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug

Exclusion Criteria:

* Patients with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (Cushing's syndrome, acromegaly, etc.)
* Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy)
* Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
* Patients with systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg
* Patients with serious renal or hepatic disease
* Patients with eGFR of \<45 mL/min/1.73 m2
* Patients who are the excessive alcohol addicts
* Patients requiring insulin therapy
* Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception