cyrilzakka/clinical-trials huggingface dataset:
Patients Empowered With Digital Scripts: ScalaMed

A prospective qualitative and quantitative controlled study, exploring the impact of patient centred digital prescriptions on health, in patients with chronic health conditions.

ScalaMed is an innovative new consumer centred solution for securing prescriptions through a blockchain solution - a cryptographic distributed database, that can give consumer access to their prescriptions at all times. It aims to solve interoperability challenges that exist in healthcare, by creating a ledger of prescriptions, and giving consumers access to this information to own and share as they need. The solution will be accessed through an application available on a smart phone, will be fully compliant with security and privacy laws, and will be made available to consumers, clinicians, and pharmacies enrolled in this study free of charge. The system also allows patients to monitor the usage of their prescriptions - eg when they need a new one, and allows them to choose how and where they want to use their prescriptions like with paper.

This study will explore whether empowering consumers with their digital prescriptions in a digital format through a blockchain based methodology of storing and accessing their data, will improve the flow of clinically important information, improve the frequency of data sharing, improve the self-management of the patient, improve adherence to treatments, reduce interactions and adverse events associated with medications, reduce the burden on clinical practice, improve efficiency, reduce the amount of paper, increase consumer engagement and improve patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-85
* Cognitively able to understand instructions and care for themselves
* Lives in the community (not institutionalised)
* Owner of a smartphone and able to use Apps
* On 3 or more chronic prescription medications
* Informed consent as documented by signature (Appendix Informed Consent Form)
* Has had experience with prescriptions in Australia for at least 1 year
* For the clinicians - any clinician who is using the ScalaMed prescription system in the Holdsworth House
* For pharmacists - who are utilising the ScalaMed system in one of the four clinics

Exclusion Criteria:

* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study due to language problems, psychological disorders, dementia of the participant
* Previous enrolment into the current study
The Contribution of Lp-PLA2 Level to the Presence of Coronary Plaques in Patients With Non Alcoholic Fatty Liver Disease

The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population. The aim of the investigators study is to diagnose early coronary artery disease in NAFLD patient by measuring of PLA2. The investigators expect that PLA2 will higher in patients with patients with combination of CAD, unstable plaque and NAFLD.

Background: The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population. The aim of our study is to diagnose early coronary artery disease in NAFLD patient by measuring of PLA2.

Methods: 60 patients with chest pain and low to intermediate risk for coronary events will undergo Cardiac CT and blood test measurement of enzyme PLA2, markers of inflammation: CRP, MDA(Malondialdehide), Paraoxonase, FFA(Free Fatty Acids), TG(Triglycerids) will performed.

CAD is defined as a stenosis of more than 50% in at least one major coronary artery, unstable plaque defined as low attenuated plaque \<30HU and fatty liver defined as difference in liver and spleen attenuation value -10HU by using CT.

Expected results : we expect that PLA2 will higher in patients with patients with combination of CAD, unstable plaque and NAFLD.

Eligibility Criteria:
Inclusion Criteria:

1. Patients at intermediate risk for significant CAD was admitted to the hospital with the diagnosis of chest pain or undergoing elective CT coronarography due to suspection of coronary artery disease.
2. Male and female 18years or older.
3. Able to provide written informed consent.

Intermediate Risk patients for having significant CAD is deﬁned as:

* chest pain or dyspnea in the presence of negative stress tests;
* the absence of chest pain but positive stress tests;
* the absence of chest pain and of positive stress tests but intermittent arrhythmias

Exclusion Criteria:

1. Acute coronary syndrome presentation:

   * ST segment deviation on ECG and/or
2. Cardiac troponin elevation.
3. Chest pain in combination with positive tests for myocardial ischemia
4. Hemodynamic instability on presentation.
5. Inability to write inform consent.
6. Age \<18 years.
7. Participation in an investigational study within the previous 30days.
A Comparison Study of the Maxi Move 5 (MM5) Device

This trial aims to evaluate the added improvements from a caregiver and patient benefit perspective.

The trial should identify the forces involved for the caregiver when manoeuvring the lift.


Eligibility Criteria:
Inclusion Criteria:

For expert patient:

* ≥18 years
* Healthy male or female
* 80-100 kg

  24 healthy volunteers (caregivers) will be recruited. They will require a strong working knowledge of passive floor lifts and patient positioning with the use of loop and clip slings.

Exclusion Criteria:

-
Determining the Efficacy of Full-time Occlusion Therapy in Severe Amblyopia at Different Ages

Objective: To find out how much visual improvement is possible in severe amblyopia using full-time occlusion therapy with an eye patch and to see if improvement is influenced by the patient's age.

Methods: An interventional clinical trial of 115 consecutive cases with unilateral, severe amblyopia was conducted at a tertiary referral center from Jan 2010 to Oct 2012. Patients were divided into three age groups: 3-7 years (n= 38), 8-12 years (n=41), 13-35 years (n=36). After a complete ophthalmological examination by a single ophthalmologist, cases with organic visual loss were excluded; cases with previous part-time occlusion therapy that had failed were included in the study. Patients were given optimal refractive correction for a month, followed by full-time occlusion therapy along with near visual activities for 3-4 hours/day. The therapy was continued until maximum visual recovery was achieved (6/6 Snellen's). Therapy was gradually reduced and stopped. Patients were followed-up regularly for the next 18 months.

Amblyopia, ('blunt vision' in Ancient Greek), also known as lazy eye, is a visual deficiency in an eye that is otherwise physically normal, or that is greater than would be expected from any structural abnormalities of the eye. There are unsubstantiated beliefs that it is more difficult to treat amblyopia in older age groups, that children that have already received failed amblyopia therapy do not respond to treatment and that full-time occlusion therapy may result in occlusion (disuse) amblyopia of the good eye. The aim of this study was to assess whether these beliefs are true. Materials and methods This was a prospective, interventional clinical trial of 115 consecutive cases with unilateral, severe amblyopia conducted at a tertiary referral center in Lahore, Pakistan, from January 2010 to October 2012. Eligibility criteria included an age of over three years, visual acuity in the amblyopic eye from 6/60 Snellen's or even counting fingers only, visual acuity in the sound eye of 6/6. A complete ophthalmic examination was performed by only one ophthalmologist (SI). This included examining the fixation pattern of both eyes, presence or absence of a phoria or a tropia by a cover-uncover test, fundus examination and color vision using Ishihara color plates. Any case with an organic cause for visual loss was excluded from the study after a thorough ophthalmological examination. Assessment of visual acuity of either eye for both near and distance acuity (Snellen's and ETDRS charts) refraction and Best Corrected Visual Acuity (BCVA) was performed by a trained optician who was masked to the study and patient's demographics.

Eligibility Criteria:
Inclusion Criteria:

* a visual acuity of 6/60 or 0.1-0.2 ETDRS in one eye and 6/6 or 1.0 ETDRS in the good eye
* strabismic amblyopia
* patients of any age were included.

Exclusion Criteria:

* structural damage to the eye (organic amblyopia)
* ametropic amblyopia
RF Applications for Residual LAA Leaks

Although the clinical impact of residual left atrial appendage (LAA) leaks still requires confirmation, its patency resulting from incomplete LAA closure may promote blood stagnation and thrombus formation, and increase the risk of thromboembolic events. The main purpose of this trial is to evaluate the safety and efficacy of percutaneous leak closure with radiofrequency energy applications.

Therapies locally targeting the LAA via occlusion, exclusion, or excision have emerged as an alternative and effective approach for stroke prophylaxis in AF patients, especially those with OAC contra-indications. Despite mounting evidence of their safety and efficacy in comparison with standard oral therapy, device-related thrombus and incomplete LAA closure resulting in residual, significant leak may occur, potentially hindering an effective stroke prevention. Radiofrequency energy has been adopted in several settings (e.g., vascular, orthopedic, aesthetic surgery) to achieve thermal-induced tissue retraction.

Eligibility Criteria:
Inclusion Criteria:

1. Age\> 18 years.
2. Presence of a significant LAA leak acutely or at follow-up.
3. Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion Criteria:

1. Life expectancy \< 2 years.
2. pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
3. presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Cutaneous Lupus Registry

Approximately 1.4 million individuals in the United States have systemic lupus erythematosus, and about 85% of these individuals develop skin lesions at some point of their disease. Cutaneous lupus erythematosus represents the skin manifestations of systemic lupus erythematosus, and can appear in people with or without systemic lupus. It is a mentally, physically, and emotionally debilitating disease that affects both the quality of life and social well-being of those affected.

The cause of cutaneous lupus is not completely understood, but likely includes multiple factors from our genes and the environment. Multiple genetic studies with small numbers of cutaneous lupus patients have been performed to determine which genes are associated with cutaneous lupus. This study aims to accumulate even larger numbers of patients to confidently identify genes and the proteins they encode that could contribute greatly to the formation of cutaneous lupus. The discovery of these genes and proteins would help not only uncover how cutaneous lupus forms, but also improve our abilities to diagnose this disease and predict its course, and stimulate new drug development.

The purpose of this study is to create a national registry of patients with cutaneous lupus patients in order to address many unknown questions about this disease. Specifically, we are interested in better understanding the causes of cutaneous lupus and improving our methods of diagnosis, prognosis, and management of this disease. We plan to use information from all patient sources, including medical histories, clinical information, laboratory data, and blood and skin samples in order to answer these questions.

Each study patient will be asked to complete a series of questionnaires, which, for example, will ask about cutaneous and/or systemic lupus history, past medical history, family history, quality of life, and sun protective habits. Patients will be also asked to donate blood and skin samples and undergo digital photography of affected areas. No treatments will be administered as part of this study, but all participants will be notified of clinical trials being conducted at UT Southwestern. This study is for the purpose of data collection only. Patients will be asked to be followed on an annual basis for five years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cutaneous lupus erythematosus and/or systemic lupus erythematosus by clinical, laboratory, and histopathological findings
* Ability to speak and read English or Spanish at a 6th grade reading level (a translator will be available with additional consent forms in Spanish)
* Ability to give written informed consent

Exclusion Criteria:

* Less than 18 years of age, since the characteristics of the disease in these subjects could be very different
* Due to a medication, in which its discontinuation results in the resolution of cutaneous lupus, since the characteristics of the disease in these subjects could be very different
* Medical conditions who do not warrant a skin biopsy
* Unable to give written, informed consent or undergo a skin biopsy and/or venipuncture for any other reason
Recreational Diving Practice for Stress Management

Within the components of Scuba diving there are similarities with meditation and mindfulness techniques. Perceived stress is known to be diminished during meditation practice. This study evaluates the benefits of scuba diving on perceived stress and mindful functioning.

Background: within the components of Scuba diving there are similarities with meditation and mindfulness techniques. Perceived stress is known to be diminished during meditation practice. This study evaluates the benefits of scuba diving on perceived stress and mindful functioning.

Method: A recreational diving group, composed of 37 subjects, was compared with a multisport control group, composed of 30 subjetcs, on perceived stress, mood, well-being and mindfulness by answering auto-questionnaires before and after a one-week long course. For the diving group, stability of the effects was evaluated one month later using similar auto-questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* More than 18
* registered at a leisure sports club

Exclusion Criteria:

* they were undergoing medical treatment for psychological issues at the time of the study
* they had taken part in a stress management program prior to recruitment for the current study
Interferon Alfa Plus Sargramostim in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of therapy. Combining sargramostim with interferon alfa may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of sargramostim in treating patients who are receiving interferon alfa for chronic phase chronic myelogenous leukemia that is in remission.

OBJECTIVES: I. Estimate the rate of major cytogenetic responses to sargramostim (GM-CSF) and interferon alfa in patients with newly diagnosed chronic phase chronic myeloid leukemia. II. Estimate the dosing, schedule, and toxic effects of GM-CSF plus interferon alfa in these patients.

OUTLINE: All patients are in hematologic remission on subcutaneous interferon alfa upon entering the study. Once a complete hematologic response is achieved and the interferon alfa dose has been stable for 14 days, patients receive subcutaneous sargramostim (GM-CSF) daily for 6 months. Patients are followed at 3, 6, 9, and 12 months.

PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Cytogenetically or molecularly proven chronic phase chronic myeloid leukemia (CML) that is Philadelphia chromosome positive OR Philadelphia chromosome negative with evidence of the BCR-ABL rearrangement or evidence of the P120 protein On interferon alfa therapy less than 6 months In complete hematologic response, defined as: WBC less than 10,000/mm3 Platelet count less than 450,000/mm3 Less than 5% circulating blasts No signs and symptoms of disease, including progressive splenomegaly

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No history of intolerance to sargramostim (GM-CSF) Must be able to perform self injection

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior interferon alfa required Chemotherapy: Prior hydroxyurea and cytarabine allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent myelosuppressive drug therapy
A Study Evaluating the Safety and Efficacy of EDIT-301 in Participants With Severe Sickle Cell Disease (RUBY)

The purpose of this study is to evaluate the efficacy, safety and tolerability of treatment with EDIT-301 in adult and adolescent participants with severe sickle cell disease (SCD).

This is a Phase 1/2 single-arm, open-label, multicenter study evaluating the safety and efficacy of a single unit dose of EDIT-301 for autologous hematopoietic stem cell transplant (HSCT) in subjects with severe SCD. Planned study subjects will be comprised of male and female adult and adolescent subjects with severe SCD, from 12 to 50 years of age, inclusive.

Eligibility Criteria:
Key Inclusion Criteria:

Diagnosis of severe sickle cell disease as defined by:

* Documented SCD genotype (βS/βS, βS/β0, βS/β+, or others) and
* History of at least two severe vaso-occlusive events per year requiring medical attention despite hydroxyurea or other supportive care measures in the two year-period prior to provision of informed consent or assent, as applicable

Karnofsky (for subjects \>16 years of age) or Lansky (for subjects ≤ 16 years of age) Performance Status ≥ 80%

Normal transcranial doppler velocity in subjects 16 years of age or younger

Key Exclusion Criteria:

* Available 10/10 HLA-matched related donor
* Prior HSCT or contraindications to autologous HSCT
* Any contraindications to the use of plerixafor during the mobilization of hematopoietic stem cells (HSCs) and any contraindications to the use of busulfan and any other medicinal products required during the myeloablative conditioning, including hypersensitivity to the active substances or to any of the excipients
* Unable to receive red blood cell (RBC) transfusion for any reason
* Unable or unwilling to comply with standard of care changes in background medical treatment in preparation of, during, or following HSCT, including and not limited to discontinuation of hydroxyurea, voxelotor, crizanlizumab, or L-glutamine
* Any history of severe cerebral vasculopathy
* Inadequate end organ function
* Advanced liver disease
* Any prior or current malignancy or immunodeficiency disorder
* Immediate family member with a known or suspected Familial Cancer Syndrome
* Clinically significant and active bacterial, viral, fungal, or parasitic infection

Other protocol defined inclusion/exclusion criteria may apply
Diagnostic Accuracy By Providers Study

The validation study is intended to provide comparative data on the diagnosis of vaginal infections as performed in primary care settings versus the diagnosis provided through standard diagnostic testing performed in a reference laboratory. The clinician and lab diagnoses will be compared to those obtained using the BD MAX Vaginal Panel on the BD MAX System.

The primary goals of this study are to:

1. Compare the level of agreement of clinician diagnosed bacterial vaginosis (BV) to vaginal swab samples evaluated for BV using Nugent's criteria and the BD MAX Vaginal Panel
2. Compare the level of agreement of clinician diagnosed trichomonas vaginalis (TV) to the laboratory diagnosis of TV identified by quantitative PCR using the GeneXpert system by Cepheid and the BD MAX Vaginal Panel.
3. Compare the level of agreement of clinician diagnosed yeast vaginitis to laboratory diagnosis of yeast identified with culture and the BD MAX Vaginal Panel.

The secondary goals of this study include:

1. Being able to describe the patterns of testing among clinicians in community practices providing routine care for women presenting with symptoms of vaginitis.
2. Describe the treatments prescribed for women presenting with vaginitis and how these prescribed treatments are distributed in women with laboratory-confirmed diagnoses.

Eligibility Criteria:
Inclusion Criteria:

1. Female, Age 18-40
2. Presenting with symptoms of vaginitis; vaginal discharge, vaginal odor, vulvar or vaginal itch, vulvar or vaginal discomfort (i.e. irritation, burning pain or vulvar edema).
3. Able and willing to provide verbal consent.
4. Willingness to undergo all study-related assessments and procedures, including the collection of multiple vaginal swabs, answer questions related to demographic and health information and follow all other study-related procedures.

Exclusion:

Women who meet any of the following criteria by participant report will be excluded from the study:

1.) Any condition that, in the opinion of the Investigator, would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Disturbed Sleep Model Study.

Subjects will be screened within 28 days. Each treatment session will consist of 2 PSG nights, study drug administration and noise model is conducted on second night.


Eligibility Criteria:
Inclusion Criteria:

* Body weight =50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive
* Healthy as judged by responsible physician.
* No clinically significant abnormality identified on the medical or laboratory evaluation and 12-lead ECG;
* The subject shows a normal sleep pattern on the basis of the evaluation of both PSG screening nights. Normal sleep will be defined as follows: LPS (Latency to persistence Sleep) \<30min., SE (Sleep Efficiency) \>85%, apnea/ hypopnea index \< 10, periodic leg movements (PLM) with arousal index \< 10. The apnea/hypopnea index is defined as "the number of apneas and hyponeas divided by the total sleep time (TST) expressed in hours". PLMI is defined as "the number of periodic leg movements associated with arousals or awakening divided by the total sleep time (TST) expressed in hour".

Exclusion Criteria:

* A positive result for the pre-study urine drug/ alcohol breath screen.
* Abuse of alcohol.
* Subject complains of sleep disturbances and /or is receiving treatment for sleep disorders.