cyrilzakka/clinical-trials huggingface dataset:
Patient-centred Smartphone AI for Protecting Vision in Macular Disease

Macular disease is the leading cause of blindness in the UK and age-related macular degeneration must undergo monitoring to determine if an injection into the eye is required that month \[required in 50% of visits\] - these patients are the 'frequent fliers' within ophthalmology units, visiting specialist hospital clinics on a monthly or bi-monthly basis. This project aims to create a home-monitoring algorithm that could in the future, enable the movement of 'monitoring' of chronic eye disease into the patients' homes: remotely identifying who does need an in-person appointment, and who can safely stay away from hospital.

The OKKO Health application is a CE-marked medical software application that aims to monitor visual function, track symptoms and treatment, and improve patient knowledge about their condition.

To monitor visual function, OKKO implements quick and engaging activities to assess visual function, contrast sensitivity, and hyperacuity. The aim of this is to develop the app to see if it is possible to detect changes in visual function in a timely manner. This would enable regular monitoring for disease progression and/or the response of visual function to treatments between clinical visits. Home monitoring may reveal information that may support the early diagnosis of worsening conditions and may enable a greater understanding of disease progression or stabilisation. Currently unpublished data collected using the OKKO Health app highlights its acceptability when collecting visual acuity compared to gold standard techniques used in clinical practice.

OKKO includes self-monitoring features which may result in an increased (disease) awareness including vision changes between clinic visits. OKKO offers symptom and treatment tracking functionality as well as education modules to increase literacy about the disease and treatment. These elements may improve the patient's self-efficacy, enable patient empowerment, and may increase the involvement of patients in their care and more thorough communication with ophthalmologists including shared decision-making processes. Thus, these psychological and behavioural changes may alleviate the patient's burden.

Eligibility Criteria:
Inclusion Criteria:

* Patients newly diagnosed with wet (neovascular) AMD in at least on eye at the start of their anti-VGEF treatment.
* Participants with wet AMD in at least one eye undergoing anti-VGEF therapy.
* Access to a device running a compatible software

  * Apple device running iOS 12 or later,
  * Android devices running Android 7.0 or later,
* Ability to read and understand English.
* Willing and able to provide informed consent.

Exclusion Criteria:

* Vision worse than 6/60 or 1.0 LogMAR in both eyes.
* Significant cognitive impairment.
* Patients who do not have the manual dexterity to tap a screen.
Retrospective Analysis of Systemic Glucocorticoid Mediated Long-term Effects, Patient Pathways and Economic Burden Across Multiple Indications

Glucocorticoids are important in the treatment of many inflammatory, allergic, immunologic, and malignant disorders. However, the adverse effects of systemic corticosteroids are one of the most common causes of iatrogenic conditions associated with chronic inflammatory diseases. Limited data are available about long-term- Systemic (cortico)steroids / systemic glucocorticoids (SCS) related side effects. Oral (cortico)steroids / systemic glucocorticoids (OCS) mediated side effects in e.g., rheumatic diseases are not consistently determined. No sufficient cohort analysis determined systematically possible side effects of SCS in the long-term. This study will close this major gap by delivering data about long-term SCS side effects (risk stratification via SCS dose, treatment duration). Therefore, the primary objective of PROGRESS is to quantify the risk of adverse outcomes among populations with specific underlying conditions (UC) with and without exposition to systemic glucocorticoid therapy in Germany. The secondary objective is to analyze the influence of dosage and time of systemic glucocorticoid therapy exposition on the risk of adverse outcomes among these populations with specific UCs. In general, it is evident that a frequent SCS exposure leads to side effects like diabetes or osteoporosis etc., which have the potential to become a major financial burden to healthcare systems. For this reason, the tertiary objective is to quantify the economic burden associated with the incidence of adverse outcomes related to SCS exposition among populations with specific UCs for the German market. The study design will be a retrospective cohort study (claims data) based on a rolling cohort design using an exact matching approach. Persons with different UCs and with SCS treatment exposition are matched to controls with UC but without SCS treatment. Matching will be performed on a quarterly basis. First patient-in is in 01/2009, last patient-in in 12/2020. The study period covers data from 01/2007 to 12/2022. The study population are adult patients with confirmed diagnosis of Bronchial Asthma, COPD, Chronic Arthritis und Rheumatism, Systemic lupus erythematosus, Vasculitis, Eosinophilic granulomatosis with polyangiitis (EGPA), Chronic rhinosinusitis (CRS), Crohn's disease, or Ulcerative colitis in Germany.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 years or older.
* Prevalent diagnosis of an underlying condition.
* At least two years of pre observation period. The same inclusion criteria apply to the matched control group, excluding the initiation of Systemic (cortico)steroids / systemic glucocorticoids (SCS) treatment.

Exclusion Criteria:

* Have a record of defined SCS-related adverse outcome within two years before index date.
* Have a history of breast cancer and / or tamoxifen prescription
Cardiac Arrhythmia Pilot Study (CAPS)

To compare the effectiveness of various drugs and drug combinations in suppressing complex ventricular arrhythmias, and to evaluate their safety.

BACKGROUND:

Epidemiologic studies had indicated that complex ventricular premature beats made an independent contribution to risk of sudden death in survivors of a myocardial infarction (MI), and did not appear to be merely a reflection of their association with relatively severe myocardial damage. The potential for reduction in mortality by identification and administration of drugs capable of safely suppressing ventricular arrhythmias was tremendous. In 1982, there was incomplete knowledge regarding which types of ventricular arrhythmias responded to various kinds of drugs. A pilot study of antiarrhythmic agents helped clarify this issue.

Numerous antiarrhythmic agents with differing pharmacologic properties and side effects had been shown to suppress ventricular arrhythmias. It had also been postulated that antiarrhythmics might raise an individual's threshold for experiencing ventricular fibrillation. There had been several published reports of large (at least l00 patients), long-term clinical trials of antiarrhythmic agents in post-MI patients. None of these had yielded statistically significant results using mortality as the response variable. This might have been due to incorrect drug selection, inadequate sample size, inappropriate choice of patients, or the lack of impact of arrhythmia treatment on mortality.

Due to incomplete knowledge as to which drug(s) and combinations of drugs were most effective, it was considered to be premature to undertake a full scale trial in 1981-1982. However, the public health problem was of sufficient magnitude to warrant a pilot study to learn more about the efficacy and safety of various antiarrhythmic drugs singly or in combination.

The protocol planning phase began in October l982. Patient recruitment started in July l983 and ended in the summer of 1985. Each patient was followed for one year.

DESIGN NARRATIVE:

Randomized, double-blind, fixed sample. A total of 502 patients were randomly assigned to 5 treatment groups consisting of encainide, ethmozine, flecainide, imipramine, and placebo.

Eligibility Criteria:
Men and women. Patients had acute myocardial infarction and ventricular arrhythmias.
Evaluation of Neuroprotective Effect of Minocycline

This process appears as a incredible and progressive event that will not stop till reattachment of RPE and neurosensory retina happened .

Process of degeneration begins from first hours of RD (Retinal Detachment) establishment Neuroprotection of photoreceptor following RD is a novel and debatable discussion encountered in recent years .

How to stop this phenomena and neuroprotective agent role in this issue are a new interest of researcher.

In the study the investigators are planning to perform a clinical trial to demonstrate the minocycline neuroprotective effect in a double blind design as this impact has been implicated previously in a animal study


Eligibility Criteria:
Inclusion Criteria:

* age over 8 years old
* gender of both sex
* normal liver and renal function
* informed consent received from all patients
* no pregnancy and no lactation
* minimal sun exposure

Exclusion Criteria:

* old RD
* diabetic retina
* previous retinal surgery CRF\& liver disfunction RD + PVR \> B Hyper sensitivity to tetracycline History previous MPC or PRP Patients unsuccessful SB (retina is off )
Early hGH Treatment of SGA Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae

SGA Infants who do not show a developmental catch-up growth within the first 6 months of life fall in the category of SGA children shown to have defects in the GH/IGF-I axis, resulting in partial hGH/IGF-I deficiency.

Up to 1/4 of children born SGA have neurodevelopmental deficits. The partial hGH/IGF-I deficiency in SGA children can be the major or contributory cause of to their neurodevelopmental deficits

To assess the effect of early growth hormone treatment given to symmetrical small for gestational age (SGA) infants not demonstrating catch-up growth on neurodevelopment and growth between birth and 6-12 months.

The study is an innovative research not previously performed for improving neurodevelopmental outcome of SGA infants. As this is the first study of its kind, the safety of use of GH has not been reported, however based on multiple studies assessing use of GH in infants and young children, it is reasonable to similarly expect no short and long-term adverse effects.

The study will take place at the Tel Aviv Medical Center only.


Eligibility Criteria:
Inclusion Criteria:

* Symmetrical small for gestational age at birth: weight + length+ head circumference below -2 SD for gestational age.
* Birth weight of 1200-2200 gr
* Follow-up of growth until age of 6-12 months
* Growth parameters below -2 SD at age of 6-12 months and absence of sufficient catch-up.
* Low growth hormone levels.

Exclusion Criteria:

* Chromosomal aberration
* Any congenital syndrome and any syndrome that shows a tendency to uncontrolled cell growth and to develop tumors
* Major congenital malformation (affecting growth or development)
* Congenital infection
* Exposure to teratogenic drugs or drugs affecting development during pregnancy
* Maternal drug or alcohol abuse.
* Maternal cancer as well as cancer in 1st degree relatives.
The Effect of Adding Metformin to the Treatment of Hepatitis C

Insulin resistance is known to adversely effect viral response to treatment in hepatitis C patients

We are aiming to study the effect of an insulin sensitizer, metformin, in viral response of hepatitis C to treatment with pegylated interferon and ribavirin in a double blind randomized controlled trial

Subjects with hepatitis C will be randomized to receive standard treatment with or without metformin. The results will be compared.

Eligibility Criteria:
Inclusion Criteria:

* chronic hepatitis C
* Iranian nationality
* Treatment naive

Exclusion Criteria:

* cirrhosis
* diabetes mellitus
* HBV/HIV coinfection
* contraindications of metformin, interferon, ribavirin
* severe medical conditions (e.g. CHF, CRF, psychosis, ...)
* not consenting
Permethrin-treated Baby-wraps for the Prevention of Malaria in Children

The scientific objective of this study is to test the protective effect of permethrin-treated lesus against P. falciparum malaria in infants and young children.

General Study Design: The proposed study is a double-blind, randomized control trial of permethrin-treated lesus to prevent P. falciparum malaria in children 6-24 months of age conducted at two sites in rural western Uganda. Participating mother-infant pairs will receive a new bed net and two permethrin-treated or untreated lesus at enrollment. The total sample size will be 400 mother-infant pairs with 200 pairs in each group. The investigators will follow participants longitudinally for six months. Participants will be instructed and incentivized to present to one of the two study clinics when a fever develops, where they will be evaluated, tested, and treated, if positive, for malaria. Participants will also attend scheduled clinic visits every two weeks for routine surveillance of adverse effects and to test for asymptomatic infection. Re-treatment and sham re-treatment of lesus will occur each month.

Outcome Measures: The primary outcome measure is the incidence rate ratio of clinical (i.e., symptomatic) P. falciparum malaria in infants and children 6 - 24 months of age. Differences in malaria infection between treatment groups will be estimated with the incidence rate ratio, defined as the ratio of the number of clinical malaria episodes per 100 person-weeks at risk in the intervention group relative to the control group. This measure was chosen as it represents the most patient-centered measure of malaria burden, reflecting not only the potential negative health consequences, but also opportunity costs associated with care seeking and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated informed consent form (ICF)
* Willing to comply with all study procedures and be available for the duration of the study
* Female of any age with a child 6 to 18 months of age at the time of enrollment
* Resident of village located in Bugoye, Maliba, or Mubuku sub-counties. Recruitment will initially focus on residents of villages within 2 km of study clinics in order to facilitate attendance, but we will not restrict enrollment to residents of these villages.

Exclusion Criteria:

* Mother or child taking any malaria chemoprevention regimen, including individuals living with HIV or exposed children who are taking cotrimoxazole that may modify risk of malaria
* Child with known sickle cell disease
* Known allergic reactions to components of the study product(s)
* Treatment with another investigational drug or other intervention
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Comparison Between Magnetic Field and Laser Therapy in Management of Trigeminal Neuralgia

Trigeminal neuralgia (TN) was defined by The International Association for the Study of Pain (IASP) as severe, sudden, usually unilateral, stabbing, brief, recurrent attacks of pain in one or more distributional branches of the trigeminal nerve. The purpose of the current study will to investigate the effect of Low level laser therapy versus electromagnetic therapy on diabetic trigeminal neuralgia pain intensity and amplitude of the compound muscle action potential of the masseter and temporalis muscles in diabetic TN patients.


Eligibility Criteria:
Inclusion Criteria:

* All participants will between the ages of 25 and 45, will of both sexes (male and female), diabetic type two patients with chronic trigeminal neuralgia, (from three to six months).
* Patients will awake, cooperative, and free of psychiatric issues (as determined by a psychologist) as well as difficulties resulting from orthopaedic or special sensory deficits.

Exclusion Criteria:

* Patients will ruled out if they developed TN due to a tumour, herpes zoster, or any other reason other than diabetes, such as significant coagulation dysfunction, cardiopulmonary dysfunction or previous invasive treatment (ethanol, radiofrequency, Gama-knife microvascular decompression, glycerinum injection).
* They will not have a previous disability in the face.
Reducing Sedentary Behaviour in Young Adults at Risk of Diabetes

Excessive periods of time spent sitting may be a risk factor for diabetes. Current lifestyles encourage large amounts of sitting (sedentary behaviour) through increasing car use, computers, and appealing screen-based home entertainment systems. Methods to help change such behaviours are now needed, particularly for those with a high risk of developing a chronic disease, such as diabetes. The investigators propose to decrease sedentary behaviour in a multi-ethnic group of young adults at risk of diabetes through an educational intervention (attending a workshop and having prompts). If successful, this could have significant public health benefits given the widespread nature of sedentary behaviour.

The rising prevalence of obesity and sedentary behaviour has lead to an epidemic of Type 2 Diabetes (T2DM). As the health and economic costs of T2DM continue to increase, there is an urgent need for an effective lifestyle intervention to prevent the development of T2DM. Our group have previously developed successful structured education programmes: DESMOND improved lifestyle, depression, illness beliefs, weight and CV risk in adults with T2DM; PREPARE increased activity levels and reduced 2 hour glucose values in people with pre-diabetes. Project STAND will assess the effect of theory driven structured education, facilitated using automated technology, on sedentary behaviour and health outcomes in young adults at risk of T2DM. Participants will be randomised to a control (C) or intervention (I) group, the latter given structured education, based on the PREPARE and DESMOND programmes, with the aim of reducing sedentary behaviour. The structured education programme will incorporate movement technology to facilitate participant feedback and self-monitoring.This will be the first UK trial to address sedentary behaviour change in a population of younger adults at risk of T2DM. Our results will provide a platform for the development of a range of future multidisciplinary interventions in this rapidly expanding high-risk population.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-30 years old
* family history of T2DM or CVD (first degree relative)
* BMI ≥ 25 (≥ 23 for south Asians)
Predictors of Failure of Empiric Outpatient Antibiotic Therapy in Emergency Department Patients With Uncomplicated Cellulitis.

Introduction: Despite several expert panel recommendations and cellulitis treatment guidelines, there are currently no clinical decision rules to assist clinicians in deciding which emergency department (ED) patients should be treated with oral antibiotics and which patients require intravenous therapy at first presentation of uncomplicated cellulitis. The objective of this prospective study is to determine potential patient risk factors associated with adult patients (\>17years) presenting to the ED with a concern about a skin or soft tissue infection who fail initial antibiotic therapy for the treatment of standard cellulitis and require a change of antibiotics or admission to hospital.

Methods: This study will be a prospective study conducted in two tertiary care EDs. Patients will be excluded if they have been treated with antibiotics for the current bout of cellulitis prior to presenting to the ED, patients admitted to hospital and those patients with abscesses only. Hired research assistants (RAs) will administer a questionnaire at the initial ED visit with telephone follow-up 2 weeks later. Treatment failure will be defined as patients requiring subsequent hospitalization, initiation of intravenous antibiotics (if oral antibiotics were prescribed initially), or a change of oral antibiotics for the original cellulitis.

Results: This study will provide a detailed profile of patient risk factors associated with treatment failure of cellulitis. The results will be analyzed and used in formulating a clinical decision rule for effective treatment of cellulitis presenting to the ED. Each of the predictor variables associated (p ≤ 0.1) with failed treatment in the univariate analysis will be considered in a multivariate logistic regression model. Additionally, treatment variability among clinicians in regard to cellulitis will be evaluated and compared to treatment failures, thus providing data on successful treatment regimens.

Conclusions: Results from this research may be used to generate a clinical prediction rule to assist clinicians in effectively treating patients presenting to emergency departments with cellulitis. Understanding which patient risk factors for treatment failure will assist clinicians in determining which patients will benefit from intravenous versus oral antibiotics.


Eligibility Criteria:
Inclusion Criteria: Adult patients (≥ 18 years) whose chief complaint was consistent with a skin or soft tissue infection (key words included cellulitis, abscess, infection, insect bite, ulcer, or rash) were screened for eligibility by ED staff or trained research assistants and invited to participate in this study once an emergency physician confirmed a cellulitis infection.

Exclusion Criteria: Patients were excluded if they were currently taking or had been recently treated with antibiotics for the cellulitis prior to presenting to the ED, if they were admitted to hospital, had an abscess only, were cognitively impaired or did not read or speak English.