cyrilzakka/clinical-trials huggingface dataset:
AI-based Measurements of Tumour Burden in PSMA PET-CT

The primary aim of the present study is to evaluate how automatically calculated (by an AI-based method) tumour burden, measured as tumour volume (TV) and as tumour uptake (TU: TV x SUVmean) in the prostate/prostate bed, pelvic lymph nodes, distant lymph nodes, bone and as the total tumour burden predicts overall survival (OS) in patients with prostate cancer (newly diagnosed and patients with biochemical recurrence).

In Sweden, prostate cancer is diagnosed in 10,000 men annually and the mortality rate of 2,400 is among the highest worldwide. Some prostate cancers are at high risk of metastatic progression to lethal disease and require correct staging or detection of recurrence and multidisciplinary treatments.

The investigators have developed an AI-based method to detect and quantify tumours and metastases in 18F-PSMA-1007 PET-CT scans in patients with prostate cancer. The method can find tumours in the prostate and metastases in pelvic lymph nodes, distant lymph nodes and in bone, both in patients referred to the PET-CT scan for primary staging of high-risk prostate cancer for secondary staging due to recurrence.

Patients referred to clinically indicated PSMA PET-CT due to either initial staging of primary high-risk prostate cancer or due to biochemical recurrence will be eligible for inclusion. The AI-based method will automatically calculate TV, TU and number of suspected lesions and this information will be stored in a database. The values will after a 5 year follow-up period be analysed with regard to overall survival (OS) and progression-free survival (PFS).

The primary aim of the present study is to evaluate how tumour burden, measured as TV and as tumour uptake (TU: TV x SUVmean) in the prostate/prostate bed, pelvic lymph nodes, distant lymph nodes, bone and as the total tumour burden predicts overall survival (OS) in patients with prostate cancer (newly diagnosed and patients with biochemical recurrence). A secondary aim is to evaluate how the AI-derived measurements predict time to biochemical recurrence in a sub-cohort of patients with newly diagnosed high-risk prostate cancer. Tertiary aims are to evaluate the difference in TV and TU measured with two different segmentation methods (a threshold of 50% of SUVmax in each lesion and a threshold of SUV 4) in relation to OS and biochemical PFS. The impact of the number of automatically calculated suspected lesions will also be investigated regarding OS and biochemical PFS as well as to the difference in tumour burden measured with AI and manually.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to a clinically indicated 18F-PSMA-1007 PET-CT scan at Skåne University Hospital, Lund or Malmö, Sweden

Exclusion Criteria:

* Patients under 20 years old
Antibiotics Versus Surgery in Acute Appendicitis

The acute appendicitis (AA) is a very common disease with a life time risk 7-8% and the highest incidence in the second decades . The aetiology of AA is still poor understood: the commonest hypothesis refers to appendix obstruction followed by impairment of wall appendix barrier and thus wall perforation and/or abscess formation1. However some studies suggest that no-complicate and complicate appendicitis are different entities allowing a different treatment. The study aims to test the no inferiority in terms of efficacy of antibiotic treatment compared to surgery in a population with high probability to suffer of 1st episode of AA.The study aims to test the no inferiority in terms of efficacy of antibiotic treatment compared to surgery in a population with high probability to suffer of 1st episode of AA.


Eligibility Criteria:
Inclusion Criteria:

* patients between 18 and 65 years old
* first episode of suspected AA diagnosed by Andersson's score or combination with abdominal ultrasound

Exclusion Criteria:

* patients with any potential immunodeficiency status
* assumption of antibiotics for different infectious disease or surgery in the last 30 days
* allergy to antibiotics established in the study protocol
* no acceptance of study protocol
* pregnancy or delivery in the last 6 months
* ASA IV or V, no Italian or English fluently speakers.
Cognitive Therapy to Sustain the Antidepressant Effects of Intravenous Ketamine in Treatment-resistant Depression

The goals of this study are: 1) to investigate the efficacy of combining ketamine with intensive cognitive behavioral therapy (CBT) to sustain the antidepressant effects of ketamine; and 2) to determine ketamine's delayed effects on learning and memory, and to explore the relationship between any ketamine-induced changes in learning and memory and duration of antidepressant efficacy, with and without CBT augmentation. Subjects with a diagnosis of MDD who are treatment-resistant to at least 2 antidepressants and have chosen to pursue clinical ketamine treatment at Yale Psychiatric Hospital will be recruited for the study.


Eligibility Criteria:
Inclusion Criteria:

* Suffering from a major depressive episode based on Diagnostic and Statistical manual (DSM) 5 criteria and having failed one or more standard antidepressant treatments during the current episode
* Hamilton Depression Rating Scale (17-HAM-D) score of 21 or more prior to ketamine treatment.
* Planned clinical treatment with ketamine at Yale Psychiatric Hospital (YPH)
* As the purpose of this study is to determine the feasibility and efficacy of CBT to sustain the antidepressant effects of ketamine, only those who achieve a clinical response (i.e., 50% reduction in depression symptoms, as measured by the Montgomery-Asberg Depressive Rating Scale (MADRS) will be eligible for randomization.
* Patients must be treatment resistant to at least two drugs used to treat depression.

Exclusion Criteria:

* Any Axis I or Axis II Disorder, which at screening is clinically predominant to their depressive episode or has been predominant to their depressive episode at any time within 6 months prior to screening
* Active suicidal thoughts with a plan
* Current or recent (\<6 months ago) substance use disorder
* Non-affective psychosis (such as schizophrenia or schizoaffective disorder)
* Inability to speak English fluently
* A clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results
* Dementia, delirium, or any other neurological or mental disease that might affect cognition or the ability to meaningfully participate in cognitive behavioral therapy (CBT).
Effect of Nutritional Intervention on the Lipid Profile of HIV-Positive Patients Who Start HAART: a Randomized Trial

Highly active antiretroviral therapy (HAART) in HIV-positive patients is associated with the development of dyslipidemia, a risk factor for cardiovascular events. The objective of this study was to evaluate the effect of dietary intervention in individuals who start HAART.

Adult patients prescribed to HAART that met the exclusion criteria were consecutively enrolled in a randomized trial:

* control (receiving general guidelines on dietary education)
* intervention (receiving general guidelines on dietary education and nutritional follow-up every 3 months)

Eligibility Criteria:
Inclusion Criteria:

* HIV-positive individuals naive to HAART, with clinical indication to start therapy

Exclusion Criteria:

* Diabetes Mellitus
* Pregnancy
* Active opportunistic disease
* Any mental deficiency
* Use of lipid profile influencing drugs
* Use of illicit drugs
Colonoscopy by Videocapsuls Versus Standard Colonoscopy. Intra-individual Comparison for the Subject With a Medium or High Risk of Colorectal Cancer.

Colorectal cancer is one of the most frequent and it prognosis is still serious. In France, diagnosis and screening applicated in numerous departements, and now in a path of generalization to the all country, is based on combination of searching blood into bowel movements (Haemoccult) for the screening of population with medium risk (age between 50 to 74 years old)and colonoscopy for the screening and diagnosis of pre-cancerous lesions for the patients with a high risk.Even if the efficiency of this strategy is proved, searching blood into the bowel movement by Haemoccult is still imperfect (a lot of false negative). Colonoscopy is not an ideal tool for screening. Indeed, its acceptability is not perfect and it constitute an invasive method, with complications, with a compulsory general anesthesia, implicating a high cost. The alternative of a screening method based on a non invasive method is required.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 years
* patient able to give his informed consent
* No colorectal, intestinal inflammatory, ischemic or evolving infectious pathologies
* No signs of stenosis of small intestine or colon
* No contraindication to anesthesia
* No participation to an other clinical study
* Patient with and indication to colonoscopy for searching of a colorectal neoplasia during a screening program OR
* Patient for who a endoscopic following is required because of familial cases or personal cases of polyps or colorectal cancer

Exclusion Criteria:

* Presence of symptoms evocating an occlusive pathology
* Recent complicated colic diverticulosis
* No informed consent
* pregnancy or no use of efficient contraception treatment
* Patient with a pace-maker or others internal medical electronic device
* Evolved nephric or cardiac insufficiencies
* Hypersensibility to Fleet Phospho Soda (or one of the excipient), bisacodyl (or one of the excipient), motilium (or one of the excipient)
* Presence of a prolactinoma
Impact of Harvest Lentil Vegetable Blend and Nutrition Education on Turkana Children's Health Outcomes

The goal of this study was to test the effect of an intervention that Integrated supplemental feeding program for children aged 6-59 months with a caregiver intensive nutrition education intervention on the health outcomes of Turkan children aged 6-59 months.

The purpose of this study was fivefold: (i) to assess child nutrition status, food security status, child feeding practices, water, hygiene and sanitation (WASH) practices, and the associated factors in Turkana County, Kenya. (ii) To assess the nutrition knowledge, attitudes, subjective norms, perceived behavioral control, and intentions towards recommended child feeding practices among Turkana caregivers of children aged 6-59 months. (iii) To assess the effect of a theory-based nutrition education intervention on nutrition knowledge, attitudes, subjective norms, perceived behavioral control, and intentions towards recommended child feeding practices among Turkana caregivers of children aged 6-59 months, (iv) to evaluate the effect of a theory-based nutrition education intervention on child feeding practices and WASH practices among Turkana caregivers of children aged 6-59 months, (v) and to assess the effect of consuming Harvest Lentil Vegetable Blend combined with nutrition education intervention on the nutritional status of Turkana children aged 6 -59 months.

In this quasi-experimental study, children in the intervention group received a daily meal of Harvest Lentil Vegetable Blend (6 days/week) for eight weeks and their caregivers' received sessions of nutrition education on infant and young child feeding practices and WASH practices. The participants in the control group were only given one bag of supplemental food on the days of data collection to compensate for their time


Eligibility Criteria:
Inclusion Criteria:

* Children between 6-59 months
* no known allergy reactions to rice, lentils, carrots and onions
* being a permanent resident of nayada and sopel villages
* willingness to participate in the study
Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476

Evaluate the percentage of subjects in remission at the end of an 8-week treatment period for three dose groups (SPD476 1.2 g/day, 2.4 g/day or 4.8 g/day, administered once daily).


Eligibility Criteria:
Inclusion Criteria:

* male \& female subjects greater than or equal to 18 years of age with newly diagnosed or relapsing mild to moderate ulcerative colitis
* general medical assessment satisfactory and no clinically significant and relevant abnormalities

Exclusion Criteria:

* severe ulcerative colitis
* subject in relapse for \> 6 weeks
* use of systemic or rectal steroids within last 4 weeks prior to baseline
* subjects with proctitis, previous colonic surgery, Crohn's disease, bleeding disorders, active ulcer disease
* subjects hypersensitive to salicylates/aspirin
* subjects with moderate or severe renal impairment
Psychometric Properties of the Self-Care Assessment Scale for 3-6 Year Old Children With Cerebral Palsy-Parent Form

This study is a methodological study to develop the self-care assessment scale-parent form of children with CP aged 3-6 years and test its validity and reliability.

Q1. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a valid scale? Q2. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a reliable scale?

This methodological research was conducted with the parents of 127 children with cerebral palsy aged 3-6 years old who were receiving education in special education and rehabilitation centers. Data were collected using the Child-Parent Information Form and the Self-Care Assessment Scale for Children with CP aged 3-6 years Parent Form (SPÇÖRS-EF). Descriptive statistics, Kruskal-Wallis, Cronbach alpha, test-retest, Kaiser-Meyer-Olkin (KMO) test, Bartlett test, explanatory factor analysis and confirmatory factor analysis were used to analyze the data. The research was conducted with the parents of children aged 3-6 years old with cerebral palsy who came to nine special education and rehabilitation centers in four provinces in western Turkey to receive physical therapy between June 5 and December 5, 2023. The sample of the study was calculated by taking at least five times the total number of items in the scale (25 items\*5=125, n=125). Non-probability random sampling method was used in sample selection. The research was completed with the participation of 127 parents. According to post hoc power analysis, this sample size was confirmed to be sufficient for 97% power (with a medium effect size d = 0.3 and α = 0.05 type I error). Criteria for inclusion in the study; The children were between the ages of 3-6 (36-72 months), lived with their parents, and the parents were at least literate and able to speak and understand Turkish. This study was conducted in accordance with the Helsinki Declaration and was approved by Aydın Adnan Menderes University Nursing Faculty Non-Interventional Ethics Committee (Date: 27.04.2023, Number: 2023/350). Verbal consent of the participants was obtained. Written permission was obtained from the special education and rehabilitation centers where the research was conducted.

Eligibility Criteria:
Inclusion Criteria:

Being between 3-6 years old (36-72 months) living with their parents

Exclusion Criteria:

be at least literate He/she was able to speak and understand Turkish.
Efficacy and Safety of Metamizole Versus Placebo as Antithermic Therapy in the Acute Phase of Ischemic Stroke

Clinical efficacy and safety of Metamizole 2 g i.v. versus placebo, as antithermic therapy in the acute phase of ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Hemispherical cerebral infarction with moderate (SSS = 30-44 points) or severe (SSS \< 30 points) deficit at the time of inclusion. However, only patients with a score between 15 and 44 points on the SSS scale will be included
* Tympanic temperature between 37 and 38 degrees Celsius. The relationship between tympanic and body temperature is as follows: tympanic temperature = body temperature + 0.3 degrees Celsius
* Onset of cerebral infarction symptoms within the last 24 hours. When the time of onset of symptoms is unknown (e.g. ictus occurred while sleeping) the last time when the patient was asymptomatic will be considered as time of onset
* Normal cerebral CT scan or with signs of cerebral infarction
* Patient's written or orally witnessed informed consent in accordance with local legislation, guidelines of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)-GCP

Exclusion Criteria:

* Patients with a history of granulocytopenia, thrombocytopenia or aplastic blood diseases of any etiology. Known hypersensitivity to salicylates, pyrazolones and other nonsteroidal antiinflammatory drugs (NSAIDs). NSAID-induced bronchial asthma
* Patients with a history indicating a life expectancy less than 30 days or patients whom the investigator thinks that it will not be possible to follow for entire 30 days
* Non-cooperative
* Patients with neurological sequelae of a previous stroke
* Cerebral hemorrhage
* Pregnancy, lactation
* Participation in another clinical trial
* Intake of acetylsalicylic acid (ASA) \> 300 mg per day, paracetamol or NSAIDs during the 24 hours prior to administration of the study medication
* Seizures at the start of the stroke
Metoprolol in Patients With HFrEF and COPD

The goal of the clinical trial was to see if Metoprolol was effective in treating patients with heart failure and chronic obstructive pulmonary disease. It will also learn about the safety of Metoprolol. The main questions it aims to answer are:

Did Metoprolol reduce the frequency of all-cause deaths and re-hospitalizations in subjects? What medical problems do participants experience after taking Metoprolol? The researchers will compare different doses of Metoprolol to see the best dose for Metoprolol.

Participants will:

Take Metoprolol 23.75mg/ day or the maximum tolerable dose of Metoprolol daily for 24 months.

Regular outpatient follow-up visits to the research center. Their symptoms and Metoprolol dosage were recorded.


Eligibility Criteria:
Inclusion Criteria:

1. A definite diagnosis of HFrEF (LVEF≤40%), NYHA II to IV , and the disease is due to ischemic heart disease or dilated cardiomyopathy;
2. A definite diagnosis of COPD with moderate or higher airflow limitation (FEV1/FVC \< 0.7 and FEV1 \< 80% of the expected value);
3. Age ≥18 years old;
4. Informed consent has been obtained and signed.

Exclusion Criteria:

1. the dose of Metoprolol before enrollment was more than 23.75mg/d;
2. Resting heart rate \< 50 beats/min;
3. Second or third degree atrioventricular block;
4. Atrial fibrillation;
5. Sick sinus syndrome;
6. Systolic blood pressure \< 90mmHg;
7. Acute attack of bronchial asthma;
8. Liver insufficiency (serum transaminase \> 3 times the normal value);
9. Renal insufficiency (eGFR \< 30ml/min/1.73m2, or serum creatinine \> 2.5mg/dL\[\> 221μmol/L\]);
10. Patients with serious physical diseases, such as cancer;
11. Patients who have a history of allergy to the investigational drug or its ingredients;
12. Participating in other clinical investigators;
13. During the study period, Patients cannot live in the selected center for a long time, which is not conducive to the follow-up;
14. Patients with disability, mobility disability, intellectual disability and other factors that may prevent normal participation in the study and follow-up, and their frailty was assessed by the FRAIL frailty screening scale; Intellectual mental status was assessed by the Mini-Mental State Examination (MMSE).
15. Poor adherence or other reasons considered by the researchers to be unsuitable for the clinical trial.
Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases

Managing patients with renal failure requires an understanding of the molecular mechanisms that lead to its occurrence (i.e. upstream of the disease), its worsening and its persistence (i.e. downstream), while also specifying the risk of worsening renal failure (risk stratification, intolerance to the treatment or complications (infectious, metabolic, cardiovascular, cancer...). Nephrogene 2.0 aims to study these different components of kidney, immune and solid organ transplantation (SOT)-related diseases.

Acute renal failure (ARF) and chronic kidney disease (CKD) are frequent pathologies (850 million people are affected worldwide). Renal failure is associated with an increased morbidity and mortality, including an increased risk of infections, drug toxicity and cardiovascular death. The causes of renal failure are numerous: metabolic (diabetes, hypertension), immunological (autoimmune diseases, monoclonal gammopathies), toxic (environment, drugs), genetic, infectious, ischemic, paraneoplastic... Any episode of ARF is also accompanied by a risk of secondary CKD (relative risk multiplied by 9).

The mechanisms leading to renal failure are multiple and combine predisposing genetic factors, inadequate intra-renal or systemic immune response, endothelial and epithelial dysfunctions, and potentially inappropriate regenerative capacity. In addition, renal failure or its treatment itself may be accompanied by additional renal lesions (e.g. nephrotoxicity of calcineurin inhibitors used as anti-rejection treatment in transplantation, hemodynamic intolerance with secondary ARF during hemodialysis sessions, iatrogenic ARF when using diuretics or inhibitors of the renin angiotensin system) or extra-renal complications (e.g. immunosuppression and infections induced by immunomodulatory therapies during autoimmune diseases or for prevention of transplant rejection; vascular diseases secondary to phosphocalcic disorders).

Patients included in the NEPHROGENE 2.0 cohort will be followed during 10 years and clinical data and biological samples will be collected at the inclusion in the cohort, at each monitoring programmed in their usual care and and at each event (infection, acute kidney injury, cancer...). Samples will be collected according to the symptoms of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients (\> 18 year of age) with kidney disease or at risk to develop a kidney disease,
* Patients followed by a practitioner of the Department of Nephrology and Organ Transplantations of the University Hospital of Toulouse (France)

Exclusion Criteria:

* consent deny
* inability of the patient or its family to give consent.
Promotion and Application of a New Three-level Etiological Diagnosis Strategy for Fever Clinics in Respiratory Infectious Diseases

Relying on fever clinics, this project evaluates the clinical diagnostic efficiency of the three-level pathogen diagnostic system, monitors changes in respiratory pathogens, and realizes real-time monitoring and early warning of acute respiratory infectious diseases in Shanghai.

This study mainly includes subjects who enter the outpatient and emergency departments, fever clinics, and wards of each center from December 2022. According to the clinical manifestations and epidemiological information of the patients, different step-by-step detection methods will be adopted to optimize the allocation of clinical resources and improve the quality of life. This study aims to improve pathogen diagnosis efficiency and achieve regional respiratory early warning.

Eligibility Criteria:
Inclusion Criteria:

1. Acute onset within one week;
2. 18-70 years old;
3. Present with pneumonia (present with pulmonary signs or radiological changes) or influenza-like illness (including the following symptoms: sudden onset of fever (\>38 ℃),plus cough and/or other respiratory symptoms such as shortness of breath plus one or more systemic symptoms (fatigue, headache ect.))

Exclusion Criteria:

1. Unable to collect nasal/nasopharyngeal swab/wash/aspirate due to structural disorder or mental problem.
2. Patients with psycological problem or unconsciousness who cannot tell the disease history and cooperate with medical examinations;