cyrilzakka/clinical-trials huggingface dataset:
Attention to Incentives

In this experiment, the investigators will test the effectiveness of a two week 20x incentive multiplier on the investigators' corporate partner's users who are (a) not notified about the incentives in advance, and (b) notified about the incentives and their purpose. The investigators will test which group shows the largest boost in walking during the two week intervention and the most lasting behavior change.

Summary:

In this experiment, the investigators will test the effectiveness of a two week 20x incentive multiplier on AchieveMint users who are (a) not notified about the incentives in advance, and (b) notified about the incentives and their purpose. The investigators will test which group shows the largest boost in walking during the two week intervention and the most lasting behavior change.

Information:

The experimental conditions will vary the type and amount of information about incentives as follows:

* Condition 1 - Uninformed: Users will receive 20x their usual incentives for two weeks, but will receive no emails informing them about the incentive program. (They may find out about incentives through the Achievemint platform.)
* Condition 2 - Informed about Incentives and Purpose: Users will receive 20x their usual incentives for two weeks, and they will receive emails informing them about the incentives (one announcement before the incentives begin, and one email every two days reminding them about the overall incentive program). These emails will contain information about the incentives and the purpose of the incentives. Condition 2 will most closely resemble the "constant" condition in the previous experiment. Roughly the same initial announcement email will go out. The reminder emails sent every two days, however, will include more information about the overall program incentives to maximize the number of participants who learn about the incentive program at some point.

Mock-ups of the email announcements and reminders are shown below.

Incentives:

The investigators' incentives will consist of multipliers for points offered via Achievemint. Since the investigators found in the investigators' last experiment that the constant incentives were the most successful, the investigators will offer these incentives to all treated participants: 20x multipliers for 14 days.

Other details:

The other details of the experiment will be the same as the previous experiment:

* Length of incentives: the investigators will offer incentives for 14 days.
* Post-intervention observation: the investigators will observe all treatment groups for at least 30 days after the intervention.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* top 30 percentiles of active walkers
* To the extent possible, given the investigators' target sample size, the investigators will exclude users who were enrolled in the investigators' previous experiment.
MIDI (MR Imaging Abnormality Deep Learning Identification)

The study involves the development and testing of an artificial intelligence (AI) tool that can identify abnormalities using patient head scans conducted for routine clinical care and research volunteer scans. A deep learning algorithm will be developed using a dataset of retrospective and prospective MRI head scans to train, validate, and test convolutional networks using software developed at the Department of Biomedical Engineering, King's College London. The reference standard will be consultant radiologist reports of the MRI head scans.

An automated strategy for identifying abnormalities in head scans could address the unmet clinical need for faster abnormality identification times, potentially allowing for early intervention to improve short- and long-term clinical outcomes. Radiologist shortages and increased demand for MRI scans lead to delays in reporting, particularly in the outpatient setting.

Furthermore, there is a wide variation in the management of incidental findings (IFs) discovered in 'healthy volunteers.' The routine reporting of 'healthy volunteer' scans by a radiologist poses logistical and financial challenges. It would be valuable to devise automated strategies to reliably and accurately identify IFs, potentially reducing the number of scans requiring routine radiological review by up to 90%, thus increasing the feasibility of implementing a routine reporting strategy.

Deep learning is a novel technique in computer science that automatically learns hierarchies of relevant features directly from the raw inputs (such as MRI or CT) using multi-layered neural networks. A deep learning algorithm will be trained on a large database of head MRI scans to recognize scans with abnormalities. This algorithm will be trained to classify a subset of these scans as normal or abnormal and then tested on an independent subset to determine its validity.

If the tested neural network demonstrates high diagnostic accuracy, future research participants and patients may benefit, as not all institutions currently review their research scans for incidental findings and clinical scans may not be reported for weeks in some cases. In both research and clinical scenarios, an algorithm could rapidly identify abnormal pathology and prioritize scans for reporting.

In summary, the aim is to develop a deep learning abnormality detection algorithm for use in both research and clinical settings.

Eligibility Criteria:
Inclusion Criteria:

* All head MRI scans with compatible sequences
* \> 18 years old

Exclusion Criteria:

* No corresponding radiologist report
* No consent for future use of the research images held within the historic database stored at The Centre for Neuroimaging Sciences (Kings College London).
* Poor image quality
Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided consent prior to any specific procedure
* Meet the The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)
* Have a minimum score of 20 on 17-Item Hamilton Depression (HAMD-17) rating scale at Visits 1 and 2

Exclusion Criteria:

* Patients who do not meet DSM-IV-TR criteria for MDD
Angiomammography and Neoadjuvant Chemotherapy

The best prognostic factor following neoadjuvant chemotherapy is the pathological complete response (pCR). pCR is defined as the absence of invading cells in the breast and lymph nodes following neoadjuvant chemotherapy treatment. Since patients with pCR have a better prognosis than those without pCR, some studies have evaluated different methods to predict pCR early in treatment. Thus, patients who do not respond optimally to treatment could be identified early and changed treatment in order to maximize the chances of pCR and avoid the morbidity of poorly effective treatments. To do this, several modalities have been proposed, including MRI, mammography, ultrasound, positron emission tomography, elastography, and serial biopsies, but these techniques have shown predictive and sometimes expensive. Nevertheless, assessment of tumor response after cycle 2 has been suggested to be appropriate for the prediction of pCR.

The main objective of this study is to compare the performance of two diagnostic modalities, namely CESM and MRI, in the evaluation of the response of a malignant breast tumor to neoadjuvant chemotherapy and the prediction of pCR. The radiological response will also be compared to the clinical response.


Eligibility Criteria:
Inclusion Criteria:

* Female aged 18 and over
* Histologically proven breast cancer by large gauge needle
* No evidence of distant metastasis
* Neoadjuvant chemotherapy with or without concomitant targeted therapy
* Breast tumor initially measurable by clinical examination

Exclusion Criteria:

* Refusal to perform the biopsy or surgery
* Pregnant or possibly pregnant woman
* Usual contraindication to contrast product

  * Significant kidney failure
  * Allergy to contrast medium
* frank hyperthyroidism
* Usual contraindications to MRI
A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid With Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD

The purpose of this study is to compare Symbicort in a pressurized metered-dose inhaler (pMDI) with formoterol and placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of COPD with symptoms for more than 2 years.
* Smoking history of 10 or more pack years
* A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit.

Exclusion Criteria:

* A history of asthma
* Patients taking oral steroids
* Any significant disease or disorder that may jeopardize the safety of the patient
A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer (POUT)

POUT is a multi-centred randomised controlled phase III trial. 345 patients who have undergone nephro-ureterectomy, are surgically staged pT2-pT4, N0-3 or are pT1 and node positive, and who are fit for adjuvant chemotherapy, will be randomised to four cycles of adjuvant platinum based chemotherapy (experimental group) or surveillance (control group). Participants will be followed up according to routine practice.

Primary endpoint: Disease-free survival (DFS)

Secondary endpoints:

* Overall Survival
* Metastasis free survival
* Incidence of bladder second primary tumours
* Incidence of contralateral primary tumours
* Acute and late toxicity
* Treatment compliance
* Quality of life


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* ≥18 years of age
* Post radical nephro-ureterectomy for upper tract tumour with predominant TCC component - squamoid differentiation or mixed TCC/SCC is permitted.
* Histologically confirmed TCC staged pT2-pT4 pN0-3 M0 or pTany N1-3 M0 (providing all grossly abnormal nodes are resected). Patients with microscopically positive margins on pathology may be entered (providing all grossly abnormal disease was resected).
* Satisfactory haematological profile (ANC\> 1.5 x 109/L, platelet count ≥ 100 x 109/L) and liver function tests (bilirubin \< 1.5 x ULN, AST and Alkaline phosphatase \< 2.5 x ULN), Glomerular filtration rate ≥30 mls/min.
* Fit and willing to receive adjuvant chemotherapy with first cycle to be commenced within 90 days of radical nephro-ureterectomy if allocated
* WHO performance status 0-1.
* Available for long-term follow-up

Exclusion Criteria:

* Evidence of distant metastases
* Pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology
* Un-resected macroscopic nodal disease
* Concurrent muscle invasive bladder cancer (patients with concurrent Non-muscle invasive bladder cancer (NMIBC) will be eligible)
* GFR \<30 ml/minute. NB Gemcitabine-carboplatin can only be given for patients with suboptimal renal function for cisplatin i.e. for GFR 30-49ml/min. Patients with poor performance status or co-morbidities that would make them unfit for chemotherapy are ineligible for the trial
* Significant co-morbid conditions that would interfere with administration of protocol treatment
* Pregnancy; lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception (male patients should also use contraception if sexually active);
* Previous malignancy in the last 5 years except for previous NMIBC, adequately controlled non melanoma skin tumours, CIS of cervix or LCIS of breast or localised prostate cancer in patients who have a life expectancy of over 5 years upon trial entry.
Cost-Effectiveness Study Of The Treatment Of Attention Deficit/Hyperactivity Disorder In Brazil

This study is an open-label, 6 month trial, of immediate release methylphenidate (MPH-IR) for children with ADHD aimed at assessing whether the observable behavioral changes seen during treatment are associated with potentially more stable underlying modifications in brain functioning (resting-state functional connectivity). Additionally, we will also be looking at treatment effects on neuropsychological processes and reading skills. This information will contribute to the first Brazilian study assessing the cost-effectiveness of the treatment of ADHD. Children with ADHD will be compared to a sample of sex and age-matched sample of typically developing children.


Eligibility Criteria:
Inclusion Criteria:

The study will include 20 boys aged 8 to 10 years old, regularly enrolled in local schools and directed to the research through advertisement in the media, contact with schools or directly referred to the Attention Deficit/Hyperactivity Program (ProDAH/HCPA) by primary care services for assessment and treatment. Only children with a primary diagnosis of ADHD or with the comorbidity ADHD + reading disorder or ADHD + ODD will be included. Only drug-naïve subjects will be apt to participate in the study.

Exclusion Criteria:

Children who fit into one or more of the following conditions will not be considered eligible to take part in the study: (1) they are outside the age range specified; (2) they are not regularly enrolled and attending school; (3) they have a history of prior or current treatment with psychoactive drugs or psychotherapy; (4) they are mentally retarded (Overall IQ\<80); (5) they have a main diagnosis differing from ADHD, including children with other psychiatric or neurological diagnoses
Autologous Bone Marrow Mononuclear Cells Therapy in Diabetic Lower Limb Ischemia

This study is to evaluate the safety and efficacy of autologous bone marrow mononuclear cells transplantation in diabetic patients with lower limb ischemia.

Diabetic lower limb ischemia as severe complication of diabetes influences the life quality of patients and currently the effective treatment for the disease is lacking. Bone marrow mononuclear cells have been proved to have multiple functions including the differentiation and proliferation. In animal model, bone marrow mononuclear cells could induce angiogenesis and may have therapeutic usage for ischemia disease. The investigators thereby design the study to investigate the possible therapy of diabetic lower limb ischemia with autologous bone marrow mononuclear cells. Patient with diabetic lower limb ischemia was treated with colony stimulating factor for improvement of bone marrow hematopoiesis. Then bone marrow was taken and mononuclear cells were isolated with deleting erythrocyte by density gradient centrifugation. Bone marrow mononuclear cells were transplanted into ischemia regions of lower limb through intramuscular injection. The investigators investigated the safety of the therapy with life signs like temperature, pulse, blood pressure, routine analysis of blood and urine etc. post the transplantation. And the efficacy was evaluated with the measurement of ulcer size, rest pain score, cold sensation score, resting ABI, resting TcPO2, collateral vessel score and skin microcirculation.

Eligibility Criteria:
Inclusion Criteria:

1. fontaine's stage 2-4 or resting ABI \<0.7
2. age between 20 and 80 years old
3. sign informed consent, voluntary subjects
4. diagnosis of diabetic lower limb ischemia

Exclusion Criteria:

1. poorly controlled diabetes (HBA1c\> 7.0%) and proliferative retinopathy (III-IV stage)
2. malignancy history in the past five years or serum level of tumor markers elevated more than doubled
3. severe heart, liver, kidney, respiratory failure or poor general condition can not tolerate bone marrow mononuclear cells transplantation
4. serious infections (such as cellulitis, osteomyelitis, etc.)
5. pregnant female, or reproductive age female who wants to give birth throughout the course of the study
6. life expectancy less than half a year
A Study to Investigate the Mass Balance of BTD-001

This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects to assess the mass balance recovery of carbon-14 (14C)-BTD-001.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males aged 30-65 years old
* BMI between18.0-35.0 kg/m2 unless investigator deems not clinically significant
* Regular daily bowel movements
* Provide written consent
* Agrees to protocol specified contraception

Exclusion Criteria:

* Received any investigational treatment within last 3 months
* Subjects who are study site employees, or immediate family members of a study site or sponsor employee
* Subjects who have previously been enrolled in this study
* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption in males \>21 units per week
* Current smokers and those who have smoked, including nicotine replacement or e-cigarates within the last 12 months.
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
* Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
* Clinically significant abnormal lab results
* Positive drugs of abuse test result
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
* Evidence of renal impairment at screening
* History of or current seizure disorder or history of syncope, unexplained loss of consciousness or seizure in the past 3 years
* Clinically significant medical/psychiatric history findings, or physical/neurological examination findings or significant history of or current suicidal ideation or behaviour
* History of or current significant pulmonary, cardiac, renal, hepatic, chronic respiratory, gastrointestinal, neurological or psychiatric disease, substance dependence, porphyria, malignancy (with exception of local cutaneous squamous or basal cell carcinomas or local cervical squamous cell cancer resolved after resection) or hypothyroidism
* Subjects with QT interval corrected for heart rate according to Fridericia's formula \>450 msec
* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
* Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
* Donation or loss of greater than 400 mL of blood within the previous 3 months
* Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than up to 4 g per day paracetamol) or herbal remedies
* Failure to satisfy the investigator of fitness to participate for any other reason
The Effect of Propolis Mouthwash Compared to Chlorhexidine Mouthwash on Oral and Cardiovascular Health

The oral microbiome has recently emerged as a key contributor in nitric oxide (NO) homeostasis and vascular control by increasing nitrite bioavailability. Antibacterial mouthwash containing chlorhexidine has been shown to be effective in inhibiting the nitrate-reducing activity of oral bacteria, and increasing blood pressure in normotensive and hypertensive individuals. Recent research has also shown that chlorhexidine mouthwash lowered salivary pH and increased salivary lactate and glucose. This was also associated with changes on the activity and diversity of oral bacteria that are susceptible to increase the risk of periodontal disease. On the other hand, mouthwash containing propolis has similar antimicrobial effects than chlorhexidine, but adding some positive outcomes such as increased salivary antioxidant capacity. This may suggest that propolis mouthwash modulates the activity/diversity of oral bacteria. Thus, this study aims to investigate the effect of propolis mouthwash on the nitrate-reducing activity of oral bacteria and vascular function compared to chlorhexidine in healthy humans.

Methods:

Participants: Adult healthy and non-smoker individuals will be recruited. The study will be approved by the Human Ethics Committee of the University of Plymouth.

Main protocol: Participants will visit the laboratory on two different occasions. At the first visit, basic anthropometrical measurements will be taken before to collect a blood (6 mL) and saliva (3 mL) samples under fasting conditions. Then, the nitrate reducing capacity of oral bacteria will be measured using a 10 mL of a free-nitrite water solution containing sodium nitrate. Participants will rinse their mouth for 5 min. Then, the mouth rinse will be collected into a sterile tube to analyse the absolute concentration of nitrite. Following this, blood pressure will be taken in triplicate on the left arm using an electronic sphygmomanometer. Then, microvascular function will be measured on the left forearm (extensor digitorum) using a hyperaemia reactive test. At the end of this visit and following a double-blind and non-cross over design participants will be allocated in one group: 1) chlorhexidine mouthwash or 2) propolis mouthwash. Participants will be given 14 tubes of 10 mL of mouthwash to rinse their mouth twice a day for a week before to return to the laboratory a week later and to undertake the same measurements.

Eligibility Criteria:
Inclusion Criteria:

Healthy individuals between 18 and 50 years old

Exclusion Criteria:

1. Smoking
2. To have hypertension, dyslipidaemia, diabetes, cancer or other physiological and mental disorders
3. Existing interventions affecting the oral bacteria: mouthwash, tongue scrapes
4. To have taken antibiotics within the last month.
5. In females, to have irregular menstrual periods, less than or greater than 28 days over the last 3 months