cyrilzakka/clinical-trials huggingface dataset:
The Ocular Microbiome in Patients With Dry Eye Disease

The primary objective of this study is the characterization of the ocular microbiome in a healthy cohort and in patients with dry eye disease using whole-metagenome shotgun sequencing. Secondary objectives are the identification of differences between the ocular microbiome of healthy controls and patients with dry eye disease as well as between the ocular and the gut microbiome.

Dry eye disease is considered to be the most common ocular surface disease worldwide. Recent studies revealed that the ocular microbiome plays an important role in maintaining ocular surface homeostasis and health. Commensals colonizing the ocular surface seem to support the local innate immune system. As the ocular microbiome coordinates several functions together with ocular mucosal and immune epithelial cells, alteration of the microbiome can lead to changes in the integrity of the ocular surface. This can lead to the development of ocular surface related diseases such as dry eye. Inflammation seems to be a key component of dry eye disease in terms of being a propagator as well as a consequence. In contrast to earlier approaches of identifying the microbiome by cultivating with only limited results, it is now possible to provide more details regarding all microbiota residing on the ocular surface due to modern sequencing techniques. Thus, the overall aim of this study is the identification of the role of the ocular microbiome in dry eye disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients willing to sign informed consent
* Patients 60 years of age or older

Exclusion Criteria:

* Patients not willing or able to sign informed consent
* Patients younger than 60 years
* Smoking
* Wearing contact lenses
* Recent (3 month) history of use of systemic and/or topical antibiotics
* Usage of medical eye drops (Lacrycon and other moisturizing eye drops are allowed)
* Recent (3 month) history of ocular surgery
Feedback Intervention and Treatment Trial in Patients With Out-of-Hospital Cardiac Arrest

The trial collects and analyzes data from Cardiac Arrest Centres in patients with out-of-hospital cardiac arrest (OHCA).

With around 70,000 cases per year, out-of-hospital cardiac arrest (OHCA) is one of the most common causes of death in Germany. Only less than 10% of patients with an OHCA can currently be discharged with a satisfactory neurological outcome. The FITT-OHCA trial is a quality management project and collects data from Cardiac Arrest Centres on pre-hospital care and early post-resuscitation treatment in a standardized manner. The aim is to optimize the treatment process in patients following successful prehospital resuscitation through systematic data collection and feedback to the members of the rescue and treatment chain. The study includes cluster randomization of the participating hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Patients after cardiac arrest

Exclusion Criteria:

* refused register participation by patient or legal representative
Visual Feedback in Lower Limb Rehabilitation

Severe Acquired Brain Injury (sABI) is defined as "an encephalic impairment that occurs after birth and is not related to a congenital or degenerative disease.

This impairment may be temporary, or permanent, and cause partial or functional disability or psychosocial distress." In Italy there are at least 10-15 new cases of sABI per year per 100,000 inhabitants; the estimated prevalence is about 150,000 cases per year. Often, people with sABI present focal neurological deficits, including alterations in strength, sensitivity, coordination and gait.

Most of the rehabilitation protocols for people with sABI are derived from post-stroke studies, caused by lack of evidence on specific rehabilitation of people with sABI. Rehabilitation of people with sABI should begin as soon as possible, to prevent the onset of retractions and decubitus, and to regain joint mobility, strength, and coordination.

OMEGO® (Tyromotion) is a newly developed device used in lower extremity rehabilitation, that provides visual and auditory feedback.

Specifically, OMEGO® contains several games developed to enhance and promote learning behaviors, that simulate activities of daily living. The use of devices such as cycle ergometers is recommended in the rehabilitation of people with sABI; however, there are no studies demonstrating the effect of cycle ergometer training in association with visual feedback.

The purpose of this study is to evaluate, both in people without apparent pathology (hereafter identified as "healthy") and in people with sABI, whether visual feedback during OMEGO® exercise modifies brain connectivity, emotional drive, and lower limb performance during a lower limb-specific motor rehabilitation task.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis os severe Acquired Brain Injury (sABI)
* Trunk Control Test score greater or equal to 48
* Motricity Index Lower Limb score greater or equal to 18
* Clinical stability
* Patient/Caregiver ability to understand ans sing the informed consent

Exclusion Criteria:

* Disorder of consciousness (mininally concious state or vegetative state)
* severe visual impairment (central or peripheral, prior or acquired after the scute event)
* presence of severe cognitive impairment
* presence of global aphasia or presence of severe apraxia
Giant Cell Arteritis: Improving Use of Ultrasound Evaluation

Giant cell arteritis (GCA) is an inflammatory disease causing new, unaccustomed headache in the elderly and which can lead to blindness in 20-30% of untreated cases. The study group have previously shown that ultrasound is a viable non-invasive alternative to temporal artery biopsy in diagnosing GCA. However, there is significant variation in ultrasound assessment (measuring a dark "halo" around the abnormal blood vessels) between sonographers in different centres, requiring a labour intensive and time consuming training programme. The study group propose to standardise the training programme, and use ultrasound and clinical evaluation to define changes occurring over time and with treatment in patients with a diagnosis of GCA made based on ultrasound changes alone. The study group will explore the use of algorithms to automate or semi-automate image interpretation.

Objectives and Project Plan:

* Project Purpose:

The purpose of the project is to develop the technology to reliably acquire and analyse ultrasound images through the use of a training programme which are comparable to those from scanning by an expert sonographer in the diagnosis (i.e. as a diagnostic tool) and monitoring of patients with GCA following treatment (i.e. as a response indicator), and patient stratification according to initial or early scan changes to determine the most appropriate treatment (i.e. as a prognostic tool).

* End Point:

The end point will be the production of an effective training programme which can be used to obtain reproducible accurate ultrasound images of the temporal artery which can be automatically analysed and used in real time in the management of patients with suspected or confirmed giant cell arteritis.

* Milestones:

The project is in 3 phases. In phase 1 (0-12 months) the study group will create a bank of images for training from healthy volunteers and patients with GCA; in phase 2 (13-18 months) the study group will test the programme on sonographers assessing patients with GCA; in phase 3 (19-42 months) the study group will acquire serial images, clinical data, serum and plasma from cohorts of patients with newly diagnosed and flaring GCA so that they can analyse and develop new software algorithms. The study group can use images already acquired from a previous diagnostic study in GCA, and test the algorithms on the new cohorts..

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer or
* Patient with a suspected diagnosis of GCA but found not to have GCA
* Recent diagnosis of GCA within 1 month or
* Suspected flare of GCA within one month
* Ability to provide written informed consent

Exclusion Criteria:

* Unable to provide written informed consent
Impact of a Personal Digital Assistant (PDA) - Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients

With this study the investigators will test, in a randomised clinical trial (RCT), the efficacy of a behavioral dietary adherence enhancement intervention paired with PDA-based dietary self-monitoring for controlling sodium intake. Seventy hemodialysis patients will be recruited from units in Pittsburgh, Pennsylvania. Participants will be randomized to a 4-month PDA-based dietary counseling intervention or to a 4-month attention control. Potential participants will be stratified by whether or not they have diabetes. Data on primary and secondary outcomes will be obtained at baseline and four months. Primary dependent variables are:

1. adherence to dietary sodium targets as assessed from 3-day food recalls,
2. average monthly interdialytic weight gain, and
3. average pulse pressure. Secondary dependent variables are:
4. adherence to dietary targets for calories, protein, carbohydrates, fats, saturated fats, potassium, and phosphorus, as assessed from 3-day food recalls, (5) serum potassium and phosphorus levels determined on a monthly basis, and (6) nutritional status as determined from serum albumin. Laboratory data, interdialytic weight gain, and blood pressure data will be obtained per dialysis center routine and abstracted from the medical record. Three-day food recalls will be obtained at baseline, 4 and 8 months and analyzed using the Nutrient Data System.


Eligibility Criteria:
Inclusion Criteria:

* Those individuals who are 21 years of age or older
* Literate
* Community-dwelling adults
* Receiving maintenance HD for at least 3 months

Exclusion Criteria:

* Individuals who cannot read or write
* Those who do not speak English
* Those who plan to move out of the area or change dialysis centers within the next 6 months
* Those with a terminal illness and life expectancy of less than 12 months
* Those who are scheduled for a living donor transplant
* Individuals who cannot see the PDA screen or use the stylus to make selections from the PDA screen.
* Those individuals with a score ≤ 26 on the Mini Mental Status Exam.
* Also excluded will be individuals who are living in a nursing home or personal care facility, who would have limited control over their dietary intake.
Safety and Efficacy of Inhaled Iloprost in Pediatric Patients With Pulmonary Arterial Hypertension

The purpose of this study is to evaluate the safety and effectiveness of iloprost for PAH in children who are between the ages of 3 and 18 years old.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 3-18 years
* Diagnosis of PAH due to IPAH, connective tissue disease, or congenital heart disease
* Pulmonary arterial hypertension confirmed by a cardiac catheterization, with mPAP \> 25 mmHg at rest, PCWP or LVEDP ≤ 15 mmHg, and PVR ≥ 240 dynes/sec/cm-5 (ie, ≥ 3.0 units m2)
* NYHA/WHO functional Class II, III, or IV
* Have had a 6-minute walk test (6-MWT) performed within the 3 months preceding the screening visit (if ≥ 8 years of age)
* Have had cardiopulmonary exercise testing (CPET) performed within the 3 months preceding the screening visit (if ≥ 8 years of age and \> 130 cms in height. CPET testing will be conducted on NYHA/WHO Class IV patients at the discretion of the Principal Investigator)
* If receiving therapy for PAH, on a stable dose and regimen for at least 3 months prior to the screening visit
* If receiving digoxin, diuretic, or oxygen therapy, on a stable dose and regimen for at least 30 days preceding the screening visit
* Must demonstrate the ability to appropriately use the nebulizer device as part of the screening process

Exclusion Criteria:

* Prior use of prostacyclins or prostacyclin analogues within 3 months prior to screening
* Portal hypertension or clinically relevant hepatic disease
* Eisenmenger syndrome with resting SpO2 \<88% on room air
* Clinically relevant asthma or other chronic lung disease, such as bronchopulmonary dysplasia, cystic fibrosis, or repaired or unrepaired congenital diaphragmatic hernia
* Diagnosis or current evidence of active lung infection or clinically relevant hemoptysis
* Left-sided heart disease, including valvular disease or heart failure
* Initiation or dosage adjustment of PAH-specific therapy within 3 months prior to screening
* Initiation of treatment with digoxin, diuretics, anticoagulation, or oxygen therapy within 30 days prior to screening
Feasibility Study: Lifting and Tightening of the Elbows

Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on the elbows. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve skin laxity above the elbows. Masked assessment of pre- and post-treatment photos will be performed. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 21 to 65 years.
* Subject in good health.
* Mild to moderate skin laxity on the elbows.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
* Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Excessive subcutaneous fat around the elbows.
* Excessive skin laxity around the elbows.
* Significant scarring in areas to be treated.
* Significant open wounds or lesions in the area to be treated
Management of Patients With Chronic Obstructive Pulmonary Disease in Granada: a Clinical Audit

It is actually unknown how are the COPD clinical guidelines followed in primary care in Andalusia, specially for diagnosis and follow up of patients with this diseases. Detection of areas for improvement in COPD healthcare can be useful in order to implement improvement programs. This project is a clinical audit among primary care centres in Granada attending patients with COPD in the public health system

The aim of this study is to audit the attention to people with COPD among primary care centres in Granada, as well as how clinical guidelines are followed and other recommendations. The study will comprise medical records from more than 3000 patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults (men or women) aged more than 40 years old
* Diagnostic code in Andalusian clinical records (Diraya) in accordance with ICD-9 (Diagnostic codes 496, 492.8, 494.0, 491.20, 493.2)
* Current of former smokers of at least 10 pack- years
* Patient with a minimum follow up of 1 year, who have been assisted in a scheduled primary care appointment at inclusion date.

Exclusion Criteria:

* Patients with a diagnostic code for COPD attended at primary care office, but without information related with COPD in the previous year.
* Patients currently involved in any clinical trial or research study related with COPD.
* Those patients excluded will be collected in an exclusion causes chart for each centre. These patients will not affect overall number of patients targeted for each centre.
Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients

This study is designed to evaluate the effectiveness of two types of spinal cord stimulation programming types, in comparison to each other as well as patient baseline data.

In this study patients have been implanted with an Abbott spinal cord stimulator capable of delivering both tonic (continuous) stimulation as well as Burst (intermittent) stimulation. Patients are programmed to be in both stimulation modes for a study period of 4 weeks, after which their pain symptoms are evaluated on a variety of surveys: McGill Pain Questionnaire (MPQ), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS), Epworth Sleepiness Scale (ESS), Insomnia Severity Index (ISI), Numerical Rating Scale (NRS) and Global Improvement. They also undergo Quantitative Sensory Testing (QST), where thermal, mechanical, vibration and pressure stimuli are applied to the patient and detection limits are documented.

Eligibility Criteria:
Inclusion Criteria:

1. Albany Medical Center neurosurgery patients with chronic leg and/or back pain, that have, or are going to have, spinal cord stimulator implantation.
2. Patients are \>/= 18 years old at the time of enrollment.
3. Patients must be: fluent in English; mentally competent; able to read and answer questionnaires; complete pain assessments; and give informed consent.

Exclusion Criteria:

1. Patients less than 18 years old.
2. Patients unable or unwilling to: read and answer questionnaires; complete pain assessments; and give informed consent.
The Effects of Smartphone Addiction on Pinch Strength, Muscle Stiffness, and Hand/Wrist Function in Young Adults

Smartphones have become an indispensable part of daily life, and their increasing use has raised concerns about various health effects, including musculoskeletal symptoms. Repetitive movements of the thumb and hand muscles can lead to issues such as tendinosis, myofascial pain syndrome, and a decrease in pinch strength. Studies have shown that musculoskeletal symptoms related to smartphone use are common among young adults and university students. Additionally, an increase in device size may place greater strain on the wrist and finger muscles. Repetitive movements can cause stiffness changes in the thumb muscles, and the relationship between these changes and pinch strength is considered an important research topic. In this study, we aimed to investigate the effects of smartphone addiction on pinch strength, muscle stiffness, hand/wrist pain, and function in young adults.

This study was designed as a cross-sectional study. Volunteers eligible to participate were first screened based on the results of the Smartphone Addiction Scale-Short Version (SAS-SV), and they were divided into two groups as Smartphone Addiction and Non-Smartphone Addiction, with a cutoff score of 31 for males and 33 for females. Subsequently, the determination of dominant hand was performed. All assessments were conducted on the participants' dominant extremity. The assessments were carried out in the following order: Patient-Rated Wrist/Hand Evaluation Questionnaire (PRWHE), the Finkelstein test, muscle stiffness measurement, and finally, pinch strength assessment, as it was considered to potentially cause fatigue. All assessments were conducted by expert physiotherapists within a total duration of 30 minutes, and participants were not followed up afterward, nor recieved any intervention.

Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in the study
* Have been using a smartphone for more than one year
* Aged between 18 and 25 years
* Send 25 or more text messages or emails per day
* Spend more than 2 hours browsing the internet and/or play games for more than one hour a day

Exclusion Criteria:

* Having radiating/radicular pain in the upper extremity
* Having neck pain
* Congenital deformities in the upper extremity and neck
* A history of diagnosed neurological, rheumatic, musculoskeletal, or cardiovascular diseases
* Having previously undergone surgery on the neck and/or upper extremity
* Having been diagnosed with De Quervain's disease or tendinopathy in the hand/hand wrist muscles before
HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)

This Phase 3 study aims to evaluate the efficacy and safety of NTLA-2002 compared to placebo in participants with HAE.

This is a multinational, multicenter, double-blind, placebo-controlled study in which approximately 60 participants will be randomized in a 2:1 ratio to receive a single IV infusion of NTLA-2002 or placebo. After the Primary Observation Period (Week 1 through Week 28), participants will have the option to receive a blinded, single IV infusion of the opposite treatment. Following the Primary Observation Period, participants will enter the Long-Term Observation Period (76 weeks), for a total of 104 weeks. Including the Screening and Run-In Period, prior to the first blinded dosing, the total study duration is approximately 28 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥16 years
2. Clinical history consistent with HAE-C1INH-Type 1 or -Type 2
3. Ability to provide evidence of HAE attacks (confirmed by the Investigator) to meet the screening requirement
4. Must agree to refrain from the use of long-term prophylactic therapies from the start of the screening period through the end of the Primary Observation Period. PI must be in agreement that it is medically acceptable for the participant to do so.
5. Must have access to, and the ability to use, on-demand medication(s) to treat potential angioedema attacks
6. Adequate chemistry and hematology measures at screening
7. Must agree not to participate in another interventional study for the duration of this trial.
8. Must be capable of providing signed informed consent. Participants 16 to \< 18 years of age, whose legal guardian provides informed consent, must provide assent.
9. Must agree to follow contraception requirements

Exclusion Criteria:

1. Concurrent diagnosis of any other type of recurrent angioedema or HAE with normal C1-INH
2. Have known negative reaction or hypersensitivity to any lipid nanoparticles (LNP) component.
3. Any condition that, in the Investigator's opinion, could adversely affect the safety of the subject.
4. Unwilling to comply with study procedures.
Effect of a Single Virtual Reality Exposure on Depressive Symptoms (Veovita-VR)

The trial aims to evaluate the effectiveness of a novel virtual reality (VR) intervention (Veovita-VR) designed to expose people with at least moderate depressive symptoms to positive emotional stimuli and positive behavioral activation, thereby reducing depressive symptoms. Therefore, 128 adults with at least moderate depressive symptoms (operationalized as a Patient Health Questionnaire (PHQ-9) score ≥ 10) will be recruited and randomized into two groups: (1) a control group that may undergo depression treatment (Care-as-Usual, CAU) and receive access to Veovita-VR 5 weeks post-baseline (i.e., CAU control group), or (2) to an intervention group that receives one Veovita-VR session immediately after randomization and may also use CAU. The primary endpoint is depressive symptom level as assessed with the Patient Health Questionnaire (PHQ-9) 4 weeks post-baseline. Additionally, depressive symptoms (PHQ-9) will be assessed 1 week post-baseline.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* PHQ-9 score ≥ 10

Exclusion Criteria:

* apparent mental health problems other than depression (e.g., diagnosis of substance use disorder, psychotic disorder or bipolar disorder)
* acute suicidality