cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Enhanced Mental Health Support for Young People

The aim of the research project is to measure the effectiveness of an early and rapid psychiatric nurse intervention at schools in improving the emotional well-being and functioning of adolescents.

In this study, the impact of a short psychological intervention on adolescent emotional well-being, symptoms, and functioning is assessed. The intervention is a short intervention based on the methods of cognitive-behavioral therapy comprising 6 weekly sessions. It is delivered by psychiatric nurses working in the schools in the City of Turku. The participants are adolescents aged 12-18 who seek student health care due to mental health problems. The goal is to recruit 150 participants. The intervention is not tied to some particular disorder and thus, the main response variable is emotional well-being. Emotional well-being is measured at both the beginning and the end of the intervention, and at 6-month follow-up using the Young Person's Clinical Outcomes for Routine Evaluation (YP-CORE) questionnaire. Effectiveness is measured as a change in the YP-CORE scores.

Eligibility Criteria:
Inclusion Criteria:

* Young Person's Clinical Outcomes for Routine Evaluation (YP-CORE) score ≥14
* Willing and able to commit to the intervention and study protocol
* Sufficient proficiency in Finnish

Exclusion Criteria:

* Other ongoing mental health treatment
* Substance use as the main problem
Effects of Routines-Based Early Intervention in Children With Autism Spectrum Disorder

Autism Spectrum Disorder (ASD) mainly has social and interaction related problems, and repetitive behaviors or interests. In recent years, studies showed that Routine-Based Early Intervention(RBEI) could increase children's development and enhance skills maintenance. Using the International Classification of Functioning, Disability and Health for Children and Youth (ICF-CY) to assess children can identify different factors under systematic analysis, then improving children's physical functions and self-care abilities. Therefore, this study will design RBEI programs for autistic children, and use ICF-CY to assess the efficacy of RBEIin body function, body structure, and participation for children with autism.

Study will enroll 30-40 children with ASD, aged 3-9 years. Children will receive subjective and objective assessment for pre-test, post-test and three-monthfollow-up after treatment. After pre-test, children will be randomized and assigned to either the experimental group or the control group. The experimental group willreceive RBEI and the control group willreceive traditional therapy. The treatment period is 12 weeks, 1-2 times a week, 1-2hours each time, and homework is given during the treatment period, allowing parents to do treatment at home. Post-test will be conducted immediately after the end of treatment period, and homework will continue until three-month follow-up conducts. It is expected that after intervention, the physical function, activities and participation, quality of life of the experimental group will improve and significantly different from the control group.

Eligibility Criteria:
Inclusion Criteria:

* Parents are willing to sign written consent form
* Diagnosed as ASD by doctor
* No neurological disease

Exclusion Criteria:

* Active medical condition
* Progressive or degenerative symptoms or illness
Vortioxetine for Treatment of Depressive Mood and Alcohol Use

This is a randomized, double-blinded, placebo-controlled, multicenter study. A total of 128 subjects will be randomly assigned to a test group or placebo group in a 1:1 ratio. Subjects will receive vortioxetine (or placebo) and acamprosate for 6 weeks according to the treatment group. Four visits will be made (weeks 0, 2, 4, 8), and on visit 2-4 (weeks 2, 4, 8) compliance, depression symptoms, and alcohol craving will be assessed.

Investigational product

* baseline: Vortioxetine 10mg (or placebo) qd + Acamprosate\*
* First 2 weeks: Vortioxetine 5-10mg (or placebo) qd+ Acamprosate\*
* Last 6 weeks: Vortioxetine 5-20mg (or placebo) qd + Acamprosate\*

  * Acamprosate 666 mg bid for bodyweight \< 60 kg; Acamprosate 666 mg tid for bodyweight ≥ 60 kg

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are able to understand the study and comply with all study procedures and willing to provide written informed consent prior to screening
* Male and female subjects aged 19 to 65 years old
* Diagnosed to have major depressive disorder and alcohol use disorder based on DSM(Diagnostic and Statistical Manual of Mental Disorders)-5 by two separate psychiatrists.
* MADRS(Montgomery Åsberg Depression Rating Scale) ≥ 26 at baseline

Exclusion Criteria:

* Subjects considered not safe to participate in the study (e.g. who has suicidal thoughts)
* Pregnant or breastfeeding
* Subjects with serious or unstable disease
* Clinical or laboratory signs of on-going hypothyroidism
* History of organic mental disorder, schizophrenia spectrum disorder, bipolar disorder, or substance abuse within 12 months (except for alcohol or nicotine abuse)
* Administration of antidepressant (MAOIs, SSRIs, SNRIs, TCAs) including vortioxetine and anti-craving medications (acamprosate, naltrexone) within 2 weeks from screening
* Administration of antipsychotic, anti-manic drugs, dopamine antagonists, anxiolytics (zolpidem more than 10mg, Benzodiazepine lorazepam equivalent dosage more than 2mg or used as alcohol withdrawal treatment) within 2 weeks from screening
* Administration of anti-depressant, fluoxetine, within 5 weeks from screening
* Subjects in need of an alcohol detoxification treatment
* Subjects in need of a hospitalization care
Applications of Fluorescence Imaging Guided Lymph Node Dissection and Fluorescence Angiography of Inferior Mesenteric Artery Assisted Left Colic Artery Preservation

To investigate the accuracy of fluorescence angiography technique IMA classification and the impact of lymph node mapping technique on the dissection of No. 253 lymph nodes.

Multiple studies, including randomized controlled trials (RCTs), have demonstrated that lymph node imaging techniques can effectively increase the number of harvested lymph nodes in gastric and colorectal cancer surgeries . However, there remains a scarcity of research specifically focused on the surgical procedure of fluorescent-guided clearance of No. 253 lymph nodes. Most existing studies have been retrospective analyses, and the need for prospective studies is evident. Further clinical research is crucial to explore the successful application of fluorescence lymph node imaging combined with indocyanine green (ICG) fluorescence angiography and its multifunctional fusion. To address this gap, investigators plan to conduct a randomized controlled trial comparing the outcomes between the use of ICG Fluorescence lymph node Imaging combined with Fluorescence angiography (FIFA group) and conventional techniques (non-ICG group) in laparoscopic rectal cancer surgery. Specifically, investigators focus will be on the preservation of the left colic artery (LCA) and the clearance of No. 253 lymph nodes. The primary objectives of our study are to simplify surgical procedures, enhance surgical safety, and provide substantial evidence for the further promotion and adoption of this technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 75 years
* Colonoscopic biopsy confirmed colorectal adenocarcinoma
* The tumor was located in the rectum or upper rectum, and the surgical method was Dxion
* No local complications before operation (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, abscess formation, no local invasion)
* Preoperative imaging diagnosis was cT1-4aNxM0
* The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia
* Sign the informed consent form

Exclusion Criteria:

* Previous surgical history of malignant colorectal tumors
* The surgical methods were combined abdominoperineal resection, Hartman operation and ISR operation
* There are contraindication of laparoscopic surgery, such as severe cardiopulmonary insufficiency
* Patients who have undergone multiple abdominal and pelvic surgeries or extensive abdominal adhesion
* Patients with intestinal obstruction, intestinal perforation, intestinal bleeding and other emergency operations
* ASA grade ≥IV and/or ECOG physical status score ≥2 points
* Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious underlying diseases can not tolerate surgery
* Have a history of serious mental illness
* Patients with uncontrolled infection before operation
Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine

We hypothesise that the addition of glutamine supplementation to both parenteral nutrition and enteral feeds in surgical newborn infants leads to a reduction in bacterial invasion.


Eligibility Criteria:
Inclusion Criteria:

* Infants who have undergone surgical procedures for congenital anomalies or
* Intestinal inflammation who require total parenteral nutrition.

Exclusion Criteria:

-
Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer

Purpose of the study is to examine the effects of 3 months of physical activity intervention on myocardial function (Left ventricular ejection fraction) in patients with HER2+ breast cancer

Primary objective: To evaluate in patients with HER2 + breast cancer, treated only by trastuzumab, the impact of three months individualized physical activity intervention (55 minutes, 3 times per week) on left ventricular ejection fraction (LVEF).

Secondary objectives: To evaluate the impact of physical activity intervention on body composition, muscle function, metabolic, hormonal and inflammatory responses, pain, fatigue and quality of life.

This study examines patients aged 18 to 85 years, diagnosed with early breast cancer with HER2 overexpression confirmed histologically and eligible to receive treatment with trastuzumab (adjuvant).

This study includes 3 assessments phases: baseline (T0), 3 months (T3) and 6 months (T6) for both arms.

The programme is organised as follows: Arm A "standard oncologic care coupled with physical activity intervention (3 times / week) " for 3 months ; Arm B (control group) "standard oncologic care".

Between T3 and T6, volontary physical activity level will follow by actimetry.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 85 years
* First breast cancer HER2 + histologically confirmed,
* WHO grade Performance Index ≤1
* Normal renal function (creatinine clearance ≥ 60 ml min-1)
* Normal heart function with LVEF ≥ 50%
* Normal liver function (AST and ALT normal)
* Physical activity certificate issued by a cardiologist or an oncologist,
* Active contraception or postmenopausal

Exclusion Criteria:

* Patients aged under 18 and over 85
* Patients having no breast cancer HER2+
* Patients with metastases
* Heart failure (LVEF ≤50%) and respiratory (O2 saturation ≤ 92%),
* Autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis)
* Symptomatic osteoarthritis,
* Cardiovascular diseases (angina or uncontrolled high blood pressure) or heart-lung (chronic obstructive pulmonary disease)
* Patients suffering from malnutrition (Body Mass Index (BMI) \<18 kg m-2) or weight loss of over 10% during the last 3 months,
* Patients with psychiatric or cognitive disorders deemed unsuitable for a sporting activity
* Pregnant or lactating Patients.
Assessment of Radiolabeled rhAnnexin V-128 in Infective Endocarditis

Intraluminal thrombi adherent to cardiac valves or atria share a common pathophysiology involving the aggregation of activated platelets with phosphatidylserine (PS) expression on the outer layer of the thrombus. They also share common complications, i.e. damages to the underlying myocardium and embolic risk related to thrombus fragmentation. The diagnostic work-up, currently relying on morphologic imaging alone (mainly echography), lacks sensitivity and does not allow to differentiate between active (renewal and growth activity) and quiescent (scarred) thrombus. It is therefore highly desirable to develop a new approach able to non-invasively provide insight on the biological activity of thrombi and to detect embolic events in a single exam.

Annexin V is a 36 kDa endogenous glycoprotein which binds PS with nanomolar affinity. Radiolabeled Annexin V has been shown to provide molecular imaging of PS expressed by apoptotic cells or activated platelets. The ability of the imaging agent to bind mural thrombus has been established in vivo in a murine model of abdominal aortic aneurysm and ex vivo in human. It has been also shown that radiolabeled Annexin V allowed in vivo detection of vegetations and secondary pulmonary emboli with high sensitivity in various animal models of infective endocarditis.

A radiolabeling kit of annexin V complying with GMP requirements has been developed (rhAnnexine V-128, Advanced Accelerator Applications - Atreus) and is currently available. AnniE is a single centre, proof of concept, interventional, open, non-randomized study aiming at evaluating the sensitivity of 99mTc-Annexin V-128 in the detection thrombus in comparison with reference imaging in patients presenting with either: 1/ infective endocarditis or 2/ atrial thrombus. The safety of the 99mTc-Annexin V-128 will be assessed in a first phase (10 first patients enrolled). Data in relation with safety of the imaging agent will be reviewed by an independent Data and Safety Monitoring Board (DSMB); in case of positive answer, the study will continue with a second phase. The data gathered in all patients (n=120) will be used to determine outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* stable clinical status
* signed informed consent
* contraception in women of childhood potential

  * Endocarditis group:
* definite ou possible endocarditis (modified Duke criteria)

  * Atrial thrombosis group:
* presence of atrial thrombosis evidenced by transesophageal echocardiography

Exclusion Criteria:

* pregnant or lactating women
* contra-indication to both MRI and CT

  * Endocarditis group:
* history of cardiac surgery in relation with the current episode
* (effective) antibiotic regimen for more than 15 days
Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries)

The purpose of this study is to train Nigerian radiologists to perform ultrasound-guided breast biopsies. Researchers will use mHealth devices to create a sustainable and practical way of training radiologists in Nigeria to perform and clinically implement US-guided breast biopsies into their practice.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older female.
* Breast ultrasound demonstrating a solid mass that is suspicious for cancer, which would typically undergo either a blind biopsy or surgical excision at the Nigerian hospital where the patient is seeking diagnosis.

Exclusion Criteria:

* Participants unwilling to sign consent.
* Participants under the age of 18.
Personalized Health Education Against the Health Damage of Novel Coronavirus (COVID-19) Outbreak in Hungary

The additional effect of personalized health education compared to general education following the internationally accepted principles will be evaluated in the prevention of the serious course of the novel coronavirus infection. It is hypothesised that personalized health education provides a greater degree of lifestyle change, thus the risk of a serious course of infection decreases.

PROACTIVE-19 is a pragmatic, randomized controlled clinical trial with adaptive "sample size re-estimation" design. Volunteers will be randomized into two groups: (A) generalized health education; (B) personalized health education. Participants will go through phone questioning and recommendation in 5 fields: (1) mental health (2) smoking habits, (3) physical activity, (4) dietary habits, (5) alcohol consumption. Both groups A and B will receive the same line of questioning to assess habits concerning these topics. In Group A: questioning will be done in sequence followed by a shared minimal intervention aimed towards improvement of these factors but without any personalized recommendation. In Group B: each assessment will be followed by specific and personalized recommendations. Assessment will be done weekly during the first month, every second week in the second month, then monthly. Considering one interim analysis for efficacy the estimated sample size is 3788 (rounded up to 3800) subject per study arm. The planned duration of the follow up is a minimum of one year.

Eligibility Criteria:
The inclusion criteria are:

1. age over 60 years;
2. informed consent to participate.

The exclusion criteria are:

1. confirmed COVID-19 infection (active or recovered);
2. hospitalization at screening for eligibility;
3. someone was already enrolled in the study from the same community/household (to avoid potential crosstalk between the study arms).
The Effects of Pythagorean Self-Awareness Intervention on Young Adolescents in Primary School-Α One Arm Clinical Trial

In this one arm clinical trial, students of the 6th grade in a primary school participated in the PSAI for 8 weeks. Self-report questionnaires and hair cortisol concentrations were used for the evaluation of the aforementioned variables at baseline and at the end of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* attended the 6th Grade of primary education.

Exclusion Criteria:

* . absence of parental informed written consent
* diagnosis of mental health problemc.
* presence of any disease that could influence glucocorticoid levels
* pharmacological treatment that could influence cortisol levels
* practice of other stress management techniques
Effect of Domperidone on the Nutrient Composition of Preterm Mother's Breast Milk

The purpose of this study is to evaluate the effect of domperidone (given to lactating mothers of very preterm infants) on the macronutrient composition of human milk.

Domperidone, a drug that enhances upper gastric motility, is an anti-dopaminergic medication that also elevates prolactin levels. It has been shown to safely increase the milk supply of lactating women. To date, researchers have analyzed the effects of domperidone on lactating woman with respect to the quantity of their milk production, adverse effects, and drug levels in the breast milk. However, the effect of domperidone on the macronutrient composition of breast milk has not been studied and current guidelines for fortification of human milk for premature infants do not distinguish between those women using or those not using domperidone. The purpose of this study is to evaluate the effect of domperidone (given to lactating mothers of very preterm infants) on the macronutrient composition of human milk.

Eligibility Criteria:
Inclusion Criteria:

* i. Mother of an infant born less than 31 weeks gestation
* ii. Women mechanically expressing breast milk using a double collecting system
* iii. Experiencing lactation failure indicated by at least one of the following: A decreasing milk supply (by greater than 30 percent from peak volume based on maternal account) An inability to provide adequate breast milk to meet the daily nutritional intake of their infant
* iv. Women who have had little or no improvement in milk production following education/counseling with a lactation consultant/Neonatal Intensive Care nurse with respect to non-pharmacological techniques.
* v. Postpartum period equal to or greater than three weeks.

Exclusion Criteria:

* i. Participants receiving any medication known to alter the effect of domperidone (e.g.cimetidine, ranitidine, famotidine, and nizatidine) or medication that interacts with domperidone (e.g. haloperidol, lithium).
* ii. Experiencing mastitis
* iii. Having a chronic or debilitating illness.
* iv. Previous breast surgery
* v. Having a known lactose intolerance
MARCH Renal Substudy

Chronic kidney disease (CKD) is an emerging problem in patients with treated HIV. Antiretroviral therapy associated renal dysfunction has been predominantly described in terms of reduced glomerular filtration (eGFR). Proteinuria is a key component of CKD and may occur in the absence of significant reductions in eGFR. This substudy is an exploration of changes in urinary protein excretion in a randomised, open-label study to evaluate the efficacy and safety of MVC as a switch for either nucleoside or nucleotide analogue reverse transcriptase inhibitors (N(t)RTI) or boosted protease inhibitors (PI/r) in HIV-1 infected individuals with stable, well-controlled plasma HIV-RNA while taking their first N(t)RTI + PI/r regimen of combination antiretroviral therapy (cART).

The aim of this substudy of MARCH is to characterize the changes in protein and salt excretion through the kidney utilising the randomised arms of the parent study MARCH. The investigators hypothesize there will be an improvement in proteinuria in those switching to maraviroc containing regimens.

Eligibility Criteria:
Inclusion Criteria:

* Provision of written, informed consent for participation in the substudy
* Enrolled into the substudy either at or before the week 0 visit of the main study
Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain

The present study aims to evaluate the use of oral nutritional supplementation in persons with some clinical conditions presenting malnutrition in some extent.

COSNUT pretends to assess the cost-effectiveness and cost-utility of oral nutritional supplementation (ONS) in persons with malnutrition and other clinical conditions. The effectiveness will be evaluated by comparing the intervention group having ONS vs a control group only with nutrition advice. The effectiveness and resource use will be collected using quality of life assessment tools, body mass index, change in malnutrition state, number of hospital admissions, medical visits...

Unitary costs for Spain will be extracted from databases and official publications and will be applied to the number of resources used in order to calculate the costs in each of the groups. Finally, the incremental cost-effectiveness ratio will be estimated and presented.

Eligibility Criteria:
Inclusion Criteria:

* \>18 y
* Nutritional status B or C (GSA criteria)
* Presenting one of the following conditions:
* Cancer patient after surgery, radiotherapy on antineoplastic treatment.
* Hip fracture
* Heart failure NYHA (New York Heart Association) III-IV.
* Breathing failure GOLD 3 o 4: FEV1 (forced expiratory volume at one second ) \<50%.
* Renal failure GFR\<30 (glomerular filtration rate )
* Participants agreeing the informed consent

Exclusion Criteria:

* Cancer patients: esophagus, stomach, pancreas and Head and neck
* Hospital admitted patients at the time of recruitment
* Life expectancy below 3 months
* Pregnant or nursing women
* Use of oral nutritional supplements in the three months prior the enrolment
* History of allergy to oral nutritional supplements
* Diabetes mellitus type 1.
* Participation in any other study at the time of enrolment
* Cognitive limitations to participate in the study