cyrilzakka/clinical-trials huggingface dataset:
AI-Augmented Skin Cancer Diagnosis in Teledermatoscopy

In this study an artificial intelligence (AI) tool for skin cancer diagnosis is implemented in a teleldermatoscopy platform. The aim is to study the effects on clinician diagnostic accuracy, management decisions, and confidence. Furthermore, this prospective randomized study investigates the role of human factors in determining clinician reliance on AI tools and the consequent accuracy in a real-world setting.

Deep-learning algorithms can potentially benefit many areas in healthcare, including the diagnosis of skin cancer using teledermatoscopy. However, there is a dearth of clinical, prospective research on human-AI interaction in diagnostic tasks that take human factors into account.

In this study we will examine the impact of such factors in a real-world setting where we integrate an algorithm in an existing teledermatoscopy platform that is used clinically at a tertiary hospital in Sweden. We will investigate what impact various implementations of AI tool output in relation to human factors have on diagnostic accuracy and management decisions.

Study subjects are recruited at the Department of Dermatology at Karolinska University Hospital and will be asked to rate prospective teledermatoscopic consults with and without AI-support. Each consult will be randomized into one of three workflows with or without one pre-defined implementation of the AI tool. Study subjects are also asked to complete two surveys with demographic information and questions relating to various human factors. Patients participating in the study will be diagnosed outside the study prior to inclusion without any involvement of an AI tool, notably by two experienced dermatologists who do not participate as study subjects.

Eligibility Criteria:
Inclusion Criteria:

* Licensed physician
* Working at a dermatology clinic
* Sufficient knowledge in Swedish
* Written consent to participate

Exclusion Criteria:

* No experience of using dermatoscopy
* Does not wish to participate
* Incomplete answers
* Physicians that are involved in the patients' clinical care relating to the teledermoscopical consult
Molecular Investigation of GENetic Factors in Cardiovascular and Immune-related Traits and Diseases Using a BIOresource of Healthy Volunteers (GENBIO)

The risk of cardiovascular disease is determined by the complex interplay between an individual's genetic make-up, lifestyle, and the environment. The researchers in this observational, cross-sectional, recall-by-genotype study are investigating two potential genetic risk factors; the SWAP70 gene is thought to play a role in the immune response modulating cardiovascular disease risk and the GMPR gene plays a role in red blood cell formation. The investigators hope to identify and characterise distinct molecular and cellular mechanisms underlying candidate functional variants identified in genetic studies of cardiovascular and immune-related human traits and diseases.

Healthy volunteers who are part of the NIHR BioResource and have already been genotyped will be invited to the study based on their genotype of the candidate functional variants of interest. Volunteers will attend a single study visit, during which they will complete procedures including a medical, demographic and lifestyle factors questionnaire; height, weight and body fat assessments; in addition to blood pressure/heart rate measurements. A minimally invasive procedure of a venepuncture will be performed to assess the primary objectives of the study.

The obtained data may (1) improve understanding of biological and disease mechanisms; (2) identify potential drug targets; and (3) improve insight into the therapeutic potential and limitations of existing and emerging therapies.

This study is funded by the UK Medical Research Council, British Heart Foundation and NIHR Cambridge Biomedical Research Centre.


Eligibility Criteria:
Inclusion Criteria:

* Have consented to be part of the NIHR BioResource;
* Are aged 18 years and above;
* Have given written informed consent to participate in the GENBIO study;
* Are carriers or non-carriers of the candidate functional genetic variant(s) of interest.

Exclusion Criteria:

Have a chronic disease, including cardiovascular diseases, autoimmune diseases and cancer.

Additional exclusion criteria to be applied at the discretion/opinion of the CI/collaborator, based on the population of available volunteers for recall and the genetic variant of interest (e.g. allele frequency):

* Have a biological first-degree relatives (parents, brothers, sisters or children) who are suffering or have suffered from a disease/condition in the opinion of the CI/collaborator that, from a genetic standpoint, may affect the study validity;
* Are current regular smokers. Regular ex-smokers are suitable if they stopped smoking \>10 years ago (regular defined as 1 pack year in both instances);
* Have ≥3 alcoholic drinks per day;
* Have a diagnosis of hypertension, or history of consistently high blood pressure readings, e.g. \>140/90 mmHg;
* Have a diagnosis of hypercholesterolemia, or history of consistently high cholesterol levels, e.g. total cholesterol level \>6 mmol/l;
* Are obese (i.e. BMI \>30);
* Are unwilling to fast and not to consume products containing alcohol or caffeine 12 hours prior to procedures.
Effect of Ketamine Intranasal Spray in Treatment of Chronic Cluster Headache

Ketamine has been used clinically IV in a very safe manner by a very small number of clinicians, to treat migraines and CH, and various other rarer pain disorders, including mixed headache and neuropathic pain clinical syndromes. In 5 cases taken from Krusz J.C. headache clinic data in Dallas, Texas US, an intranasal spray of ketamine aqueous solution of 100 µL in one nostril were dosed in treatment of patients with refractory chronic cluster headache as an alternative to IV-treatment (data not published).The net conclusion, at this point, is that intranasal ketamine is a legitimate pharmacologic treatment and is safe and has in one case series proven effective for CH rescue.

The CCH patients will be dosed with an intranasal spray containing 172.5 mg ketamine hydrochloride (150 mg ketamine base) per ml in an aqueous solution. The individual dosing includes 15 mg ketamine in an intranasal sprayed volume of 100 µL given in one nose nostril under supervision of a nurse. The treatment is initiated at T0 under a CH attack when the headache pain exceeds NRS = 6 on an NRS pain scale. The first intranasal dose of 15 mg is given at time 0 and at time intervals of 6 minutes. At 15 minutes after 3 doses (45 mg) it is decided to evaluate whether the patient is sufficiently pain relieved (e.g. NRS \< 4) or wants to receive rescue medications instead or if pain is not sufficiently relieved wants to continue until 5 dosing's (75 mg) are received at timepoints T24. The final evaluation of the treatment is performed at T30. Participants are followed up after 1-2 weeks by telehone


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age between 18 and 60 years
* Diagnose: Chronic cluster headache according to ICHD-3 criteria (1)
* Body weight ≥50 kg and BMI ≤30

Exclusion Criteria:

* Conditions that result in the participant being unable to complete the experiment
* Medical history with elevated intraocular pressure (e.g. glaucoma)
* Medical history with severe heart or liver disease
* Aneurysmal vascular disease or arteriovenous malformations
* Medical history with severe neurological disease except of headache
* BP measured at baseline before CH attack (Systolic\> 140 mmHg or / and diastolic blood pressure\> 90 mm Hg)
* Medical history with severe depression or psychosis
* A previous history of drug abuse
* Consumption of illegal drugs within the last 6 months
* Medical history of nasal abnormality or dysfunction (e.g. rhinitis)
* High disposition for larynges or apnea
* Positive pregnancy test before treatment and breastfeeding
* Known hypersensitivity to ketamine
Internet-delivered Trauma-focused Cognitive-behavioral Therapy as an Early Intervention After Sexual Trauma

The research aims to assess the practicality and implementation aspects, effectiveness, and processes of change related to Condensed Internet-delivered Prolonged Exposure (CIPE) administered as an early trauma focused intervention after sexual assault. Eligible participants are individuals seeking help at Traumamottagning Centrum för Sexuell Hälsa, Malmö who have been exposed to sexual assualt in the past two months and exhibit psychological symptoms in response to that.

The study is un-controlled with 30 participants that will undergo a brief trauma-focused Internet-based CBT treatment, delivered as a three-week treatment comprising of four modules (psychoeducation/rational, in vivo exposure, imaginal exposure and relapse prevention). The primary outcome is level of symptoms of post traumatic stress rated by the PCL-5. Secondary outcomes are level of symptoms of post traumatic stress using the Clinician Administered PTSD Scale version 5 (CAPS-5) and The International Trauma Questionnaire (ITQ), level of depression (PHQ-9), quality of life (WSAS and EQ-5D ) dropout rate, rates of inclusion, attrition, adherence,and negative effects.

Qualitative data using a semi-structured interview will be gathered from participants at the end of the treatment collecting data on participants' views on the treatment, preferences for this type of treatment and how to further improve it.

The treatment effects will be evaluated using a within-group design with repeated measurements. Participants in the study will be will recruited from patients treated for sexual assault at Traumamottagning Centrum för Sexuell Hälsa, Malmö.

Eligibility Criteria:
Inclusion Criteria:

* Experienced trauma in the past two months according to criterion A for PTSD in the DSM-5 (exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence).
* At least mild clinical symptoms assessed using the PCL-5 cut-off \>10
* ≥ 18 years
* Signed informed consent

Exclusion Criteria:

* Other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk)
* Unable to read and write in Swedish
* Receiving other psychological trauma-focused treatment
* Ongoing trauma-related threat (e.g., living with a violent spouse)
* Not stable dose of antidepressant medication the last two weeks
Automatic Segmentation Ultrasound-based Radiomics Technology in Diabetic Kidney Disease

Diabetic kidney disease is a common complication of diabetes and the main cause of end-stage renal disease. In this study, the investigator plan to enroll nearly 500 participant with/without DKD and to develop an automatic segmentation ultrasound based radiomics technology to differentiating participant with a non-invasive and an available way.

Ultrasound examination is a convenient, cheap and non-invasive method for kidney examination. However, the ability of conventional ultrasound to distinguish diabetic kidney disease from normal kidney is limited, and it is difficult to accurately distinguish between diabetic kidney disease and normal kidney only with the naked eye. In recent years, computer science has developed rapidly and artificial intelligence has been developing continuously. Much progress has been made in applying artificial intelligence in data analysis. Machine learning is a direction of generalized artificial intelligence, its main characteristic is to make the machine autonomous prediction and create algorithm, so as to achieve autonomous learning. kidney disease and deep learning are two different approaches in the field of machine learning. In this study, image omics and deep learning were used to analyze the images. Image omics extracts traditional image features, including shape, gray scale, texture, etc., and uses machine learning (pattern recognition) models to classify and predict, such as support vector machine, random forest, XGBoost, etc. Deep learning directly uses the convolutional network CNN to extract features, and completes classification and prediction in combination with the full connection layer, etc.

This study aims to explore the detection of diabetic kidney disease and its pathological degree based on automatic segmentation ultraound-based radiomics technology, mining of internal information of ultrasound images, and form a set of non-invasive monitoring of diabetic kidney disease complications development system, especially in primary medical institutions, has a broad clinical application prospect.

Eligibility Criteria:
Inclusion Criteria:

* patients with clinical diagnosis of T2DM and DKD were enrolled.
* patients with clear B mode ultrasound imaging in both side of kidney (left and right).
* No missing value in the vital clinical data such as eGFR and UACR.

Exclusion Criteria:

* Patients with large kidney space occupying disease such as kidney renal cyst and tumor were excluded.
* Ultrasound images with severe shadow or incomplete kidney border were excluded.
Real Life Long-term Adherence to Ticagrelor After PCI for Acute Coronary Syndromes

Documentation of long-term data regarding ticagrelor use and evaluation of reasons for discontinuation of ticagrelor in patients with ACS

REAL-TICA is a retrospective non-interventional study to assess the long-term use of ticagrelor in patients with ACS and to evaluate the reasons for discontinuation of ticagrelor.

For this purpose, selected sites from the ALKK-PCI registry and the respective patients will be identified. The sites' eligibility for this study includes the frequent use of ticagrelor during the acute phase of ACS. Eligible patients are characterised by the diagnosis of ACS and the use of ticagrelor during PCI.

The eligible sites will be contacted by IHF and asked to contact their eligible patients by letter to obtain informed consent of the patients for the planned 12M follow-up by IHF. A detailed questionnaire on events within the last 12 months, current symptoms, current medication and the use of ticagrelor will be added to the patients' letters. Patients then are asked to return their responses on consent to participate in the study as well as the filled in questionnaire to IHF. Alternatively, patients may choose to receive a telephone call by IHF to answer the detailed questionnaire in person. In case of essential information missing, IHF will contact the primary care physician of the patient directly to obtain information about clinical events and medications.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* ACS (STEMI or NSTE-ACS) with PCI
* Ticagrelor treatment during the acute phase
* Written informed consent for participation in the study.

Exclusion Criteria:

* None
Sibling-Support for Adolescent Girls (SSAGE)

Forcibly displaced adolescents face increased risks for mental illness and distress, with adolescent girls disproportionately affected in part due to the heightened gender inequity that often accompanies forced displacement. Although the family unit has the potential to prevent mental illness and promote healthy development in adolescents, few family interventions have employed a gender transformative approach or included male siblings in an effort to maximize benefits for adolescent girls. Therefore, the investigators propose to assess an innovative whole-family and gender transformative intervention-Sibling Support for Adolescent Girls in Emergencies (SSAGE)-to prevent mental health disorders among adolescent girls in Colombia who were recently and forcibly displaced from Venezuela. The proposed R34 study will adapt the SSAGE curriculum through human-centered design with a range of stakeholders, including Venezuelan refugees, Colombian returnees and relevant civil society organizations. The proposed study will then employ a hybrid type 1 effectiveness-implementation pilot randomized control trial (RCT) to test the program's effectiveness and mechanistic pathways as well as to explore determinants of implementation in order to establish the feasibility, acceptability, and fidelity of SSAGE. To address these aims, the investigators will enroll 180 recently arrived, forcibly displaced adolescent girls in an RCT and examine the program's effectiveness on the prevention of mental illness (through reduction in anxiety, depression, interpersonal sensitivity, and somatization symptoms) one-month post-intervention. The investigators will use contextually adapted and piloted measures to collect additional data on the hypothesized mechanistic pathways, including family attachment, gender equitable family functioning, self-esteem, and coping strategies. The implementation evaluation will employ mixed methods to assess the program's feasibility, acceptability, fidelity and barriers and facilitators to successful implementation. Potential findings can support humanitarian program implementation, as well as inform policy to support adolescent girls' mental health and to prevent the myriad disorders that can arise as a result of exposure to displacement, conflict, and inequitable gender norms in their households and communities.


Eligibility Criteria:
Inclusion Criteria:

* Live with a male and female caregiver and an adolescent male sibling or relative
* Immigrated to Colombia within the last year
* Are available, along with their family members, to participate in the SSAGE intervention for three months
* Are available to participate in survey questionnaires immediately before and one month after the intervention

Exclusion Criteria:

* None
Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate

The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD.

Every treatment period is 14-days long and there is a 7-days wash-out period in between them. The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.


Eligibility Criteria:
Inclusion Criteria:

1. Adult male or non-pregnant, non-lactating female aged between 40 and 80 years old, both inclusive.
2. Patient with a clinical diagnosis of stable moderate to severe COPD according to the GOLD classification
3. Current, or ex-cigarette smoker with a smoking history of at least 10 pack-years.
4. Patient whose FEV1 at the Screening Visit measured between 10-15 minutes post inhalation of 400 mcg of salbutamol is 30% FEV1 \<80% of the predicted normal value (i.e., 100 x Post-salbutamol \< FEV1/ Predicted FEV1 must be \< 80% and ≥ 30%).
5. Patient whose FEV1/FVC at the Screening Visit measured between 10-15 minutes post inhalation of 400 mcg of salbutamol is \< 70% (i.e., 100 x Post-salbutamol FEV1 /FVC \< 70%).
6. Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained.
7. Patient whose COPD symptoms and FEV1 values at the time of randomisation are stable compared to the Screening Visit, according to the investigator's medical judgment

Exclusion Criteria:

1. History or current diagnosis of asthma or exercise-induced bronchospasm.
2. Clinically significant respiratory conditions at the time of Inform Consent signature
3. Hospitalisation due to COPD exacerbation within the previous 3 months.
4. Signs of a COPD exacerbation or respiratory infection (including the upper respiratory tract) within the previous 6 weeks.
5. Patient who has a resting systolic blood pressure ≥ 200 mmHg, a resting diastolic blood pressure ≥ 120 mmHg or a resting heart rate ≥ 105 bpm at screening visit.
6. Clinically significant cardiovascular conditions
7. Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.
8. Presence of narrow-angle glaucoma.
9. QTc \[calculated according to Bazett's formulae (QTc=QT/RR1/2) above 470 milliseconds in the ECG performed at Screening Visit,
10. Patient who does not maintain regular day/night, waking/sleeping cycles
Vitamin D Treatment Effect for Atopic Dermatitis in Children

A double-blind study to evaluate the role of human microbiome and vitamin D in the development of atopic dermatitis.

Atopic dermatitis (AD) is a chronic relapsing inflammatory skin disease with intermittent flares, affecting approximately 15% to 20% worldwide. Atopic dermatitis is clinically distinguished by pruritus, eczematous plaques, and a defective epidermal barrier. The pathology of AD is not entirely understood. It involves a complex interplay of dysfunctions of immune response, genetic and environmental factors (such as exposure to allergens and microbes). The control of patients with AD may be difficult to be achieved in some patients; this suggests the presence of some other associated factors. The findings obtained in both clinical and observational studies revealed that the deficiency of vitamin D may be a factor to be considered in the pathophysiology of AD. Vitamin D supplementation with standard treatment yielded positive clinical outcomes in mild and moderate AD. However, the potential benefit of vitamin D and its clinical correlation in AD is still uncertain. Thus, there is a need for more detailed and prospective studies.

The investigators will enroll children with atopic dermatitis and age and gender matched healthy children in China Medical University Children's Hospital. Briefly, the investigators interviewed subjects using EASI SCORE (defined as moderate or severe patients) and collected their venous blood and microbiome samples of nasal, skin and anal swab. Then, AD subjects will be given vitamin D or placebo for 6 months in a randomized, double-blind way. The participants will be asked to return to the outpatient clinic every month to assess the severity of AD. After six months of follow-up, their blood, nasal cavity, skin and intestinal bacterial samples were taken. All microbial analysis, allergen detection, vitamin D concentration, VDR, and DBP genotype will be analyzed by the core laboratory and bioinformatics center of CMUH.

The investigators believe this study can answer the cause-effect relationships of microbiota and vitamin D in the development of AD, and design a microbiota-related preventive and treatment strategy.

Eligibility Criteria:
Inclusion Criteria:

Experimental group: Patients were 1-18 years old with EASI score moderate to severe atopic dermatitis, and atopic dermatitis was defined as three or more of the following statements to be diagnosed as atopic dermatitis:

1. skin itching
2. typical skin symptoms (including eczematous dermatitis or lichenified dermatitis) and location (mostly on the extensor side of the face and body in infants and young children, and on the flexor side of joints in adults)
3. chronic persistent or recurrent dermatitis for more than 6 months.
4. Individuals or family members with atopic constitution such as allergic rhinitis, asthma, atopic dermatitis or urticaria.

Control group:healthy children under the age of 18 (eg, healthy siblings of sick children).

Exclusion Criteria:

1. Less than 1 year old or more than 18 years old.
2. Patients with mild EASI severity of atopic dermatitis.