cyrilzakka/clinical-trials huggingface dataset:
Clinical Investigation of a New Intraocular Lens

The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Symfony Extended Range of Vision IOL.


Eligibility Criteria:
Inclusion Criteria:

* Minimum 22 years of age
* Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
* Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source
* Potential for postoperative BCDVA of 20/30 Snellen or better
* Corneal astigmatism
* Clear intraocular media, other than cataract
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent and HIPAA authorization
* Ability to understand and respond to a questionnaire in English or Spanish

Exclusion Criteria:

* Requiring an intraocular lens power outside the available range of +16.0 D to +28.0 D
* Pupil abnormalities
* Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
* Prior corneal refractive or intraocular surgery
* Corneal abnormalities
* Inability to achieve keratometric stability for contact lens wearers
* Subjects with diagnosed degenerative visual disorders that are predicted to cause visual acuity losses to a level of 20/30 Snellen or worse during the study
* Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
* Use of systemic or ocular medications that may affect vision
* Prior, current, or anticipated use during the course of the 6-month study of tamsulosin or silodosin, that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject
* Inability to focus or fixate for prolonged periods of time
* Poorly-controlled diabetes
* Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study.
* May be expected to require retinal laser treatment or other surgical intervention during the course of the study
* Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
* Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial
* Desire for monovision correction
Study on Multimodal Imaging and Molecular Imaging Techniques in Degenerative Dementia

This project is a multicenter observational study that establishes a longitudinal cohort of patients with Alzheimer's disease and other dementias based on neuroimaging, molecular imaging, biological and digital markers to explore new solutions such as dementia disease mechanism, diagnosis, condition evaluation, and prognosis assessment.

This project will build a longitudinal database based on multimodal MRI imaging information of dementia subjects, various body fluid or digital markers, and a cohort. The convolutional neural network algorithm will be used to explore the imaging characteristics of healthy controls, AD, FTD, and DLB, develop an early prediction model for degenerative dementia, and achieve early differential diagnosis of different dementia subtypes. This study further performed GE180, ASEM, and exendin-4 radionuclide imaging on some subjects who completed conventional PET (AV45, Tauvir, and FDG) imaging to explore the diagnostic efficacy of these three probes as new diagnostic probes for early AD. In addition, through longitudinal follow-up of Aβ-positive MCI patients, multimodal MRI and PET image fusion technology were used to explore the changes in fused images during their conversion to AD in order to obtain early and accurate diagnostic markers.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥50 and ≤85 years old, male or female;
* Meet the diagnostic criteria for dementia or MCI;
* Neuropsychological score: MMSE 15-28 points, CDR ≤ 1 point; ④ Patients and their families are informed and sign the informed consent form

Exclusion Criteria:

* The presence of other neurological diseases that may cause brain dysfunction (such as depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.);
* The presence of other systemic diseases that may cause cognitive impairment (such as liver dysfunction, renal dysfunction, thyroid dysfunction, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.);
* Suffering from a disease that makes it impossible to cooperate with cognitive examinations;
* The presence of contraindications to MRI;
* The presence of mental and neurological retardation;
* Refusing to draw blood;
* Refusing to sign the informed consent form.
Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)

The purpose and (primary) objectives of this study are to evaluate the efficacy, safety, and tolerability of TS-022 in adults with atopic dermatitis who have moderate to very severe pruritus (itching), following a 28-day regimen of twice-daily topical application.

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Eligibility Criteria:
Inclusion Criteria:

1. Adults, males or females, 18 - 65 years of age at the time of obtaining the written Informed Consent
2. Generally healthy subjects, who have no past or present history of any significant and/or newly-diagnosed disease or condition
3. A score of 2 (Mild Disease), 3 (Moderate Disease) or 4 (Severe Disease) on the Investigator's Global Assessment of Atopic Dermatitis (IGA) Scale
4. A score of 2 (Moderate Pruritus), 3 (Severe Pruritus) or 4 (Very Severe Pruritus) on the Five-Point Pruritus Scale
5. Patient satisfies the diagnostic criteria for AD as determined by the criteria of Hanifin and Rajka
6. Patient understands the study procedures and agrees to participate in the study by giving written Informed Consent
7. Ability to read and understand English and to provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

1. Concurrent skin pathology or recent history (within the past 5 years) of a chronic skin disease other than AD
2. Use of phototherapy, including exposure to tanning beds, within 28 days of Study Drug application
3. Taking systemic immunosuppressive drugs, biologicals, or corticosteroids therapy within (14 days), or topical immunosuppressive drugs or corticosteroid therapy (within 7 days) of Study Drug application
4. Females who are planning a pregnancy, who are pregnant, or who are breastfeeding
5. Inability or unwillingness to discontinue current AD treatment(s)
6. Inability or unwillingness to comply with study visit schedule and/or other study activities as required by the study protocol
Levosimendan Infusion in Critically Ill Patients With Cardiogenic Shock

To determine whether Levosimendan infusion in patients with cardiogenic shock and cardiorenal syndrome refractory to standard inotropic therapy, improves hemodynamics and renal function, whilst being safe.

Cardiogenic Shock or the state of systemic hypoxia albeit initially preserved intra-vascular volume and intact vascular function, is solely the result of insufficient cardiac output \[1-2\]. The ensuing centralization and redistribution of blood-volume, is induced by a stimulation of the renin-angiotensin system, as well as vasopressin and endogenous catecholamine liberation \[2-3\]. Precipitating Cardiogenic Shock has a direct effect on the kidney, also called the cardiorenal syndrome \[4\].

The overall consensus for the therapy of cardiogenic shock is the use of inotropes to increase cardiac output and reverse organ hypoxia \[2\], nevertheless their increase of myocardial and glomerular oxygen consumption make them a double edged sword to use in cardiogenic shock and more prominently in cardiogenic shock coupled with pronounced cardiorenal syndrome.

Levosimendan is an inotropic agent that was developed for the treatment of severely decompensated heart failure. It exerts its inotropic effects primarily through sensitizing Troponin C to calcium and thereby increasing contraction of cardiac myofilaments during systole \[5\]. Unlike other inotropic agents, Levosimendan acts independently of the beta adrenergic receptor \[5\]. Additionally, the effect of Levosimendan could be beneficial for the kidneys function by decreasing pre-glomerular arteriolar vasotonus whilst keeping post-glomerular arteriolar vasotonus constant \[6\].

In light of the scarce but promising literature the question arises if Levosimendan can safely ameliorate cardiac and renal function concomitantly in patients presenting the combination of cardiogenic shock and cardiorenal syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Levosimendan
* Cardiogenic Shock
* Continuous monitoring of cardiac output at the start of and during treatment with Levosimendan

Exclusion Criteria:

* Extracorporal hemodynamic support or an implanted ventricular assist device
* Previous therapy with Levosimendan during the index hospitalization
* Refusal of participation in the study
Clinical Characteristics of Patients With Sleep Apnea in Korea

Sleep-disordered breathing including obstructive sleep apnea (OSA) is an extremely common medical disorder associated with important morbidity. The purpose of this study is to understand the clinical features and course of patients with sleep apnea in Korea. Participants who are suspected of sleep apnea due to symptoms such as snoring, witnessed apneas, waking up with a choking sensation, excessive sleepiness, non-restorative sleep, difficulty initiating or maintaining sleep, fatigue or tiredness, and morning headache will be prospectively recruited at the outpatient clinic of Seoul National University Hospital. After polysomnography (PSG) or respiratory polygraphy, patients with sleep apnea including OSA and central sleep apnea (CSA) will be followed regularly. Participants not having sleep apnea (apnea-hypopnea index \< 5/hour) will only have a baseline visit. For only participants with the informed consent of donating blood, their blood samples will be collected and stored in the Seoul National University Hospital-Human Biobank (SNUH-HUB).


Eligibility Criteria:
Inclusion Criteria:

* Participants who are suspected of sleep apnea due to symptoms such as snoring, witnessed apneas, waking up with a choking sensation, excessive sleepiness, non-restorative sleep, difficulty initiating or maintaining sleep, fatigue or tiredness, and morning headache

Exclusion Criteria:

* None
Comparing Self Monitored Blood Glucose (SMBG) to Continuous Glucose Monitoring (CGM) in Type 2 Diabetes

The purpose of this study is to evaluate the use of SMBG and CGM for clinical decisions related to the management of type 2 diabetes. The secondary objective is to determine the benefit of using CGM for clinical diabetes management decision-making.

This study involves the use of the following 2 glucose monitoring methods to measure your blood sugar (glucose) levels and help manage type 2 diabetes:

1. Self Monitoring Blood Glucose (SMBG): blood glucose is measured 4-7 times each day using finger sticks and an blood glucose meter.
2. Continuous Glucose Monitoring (CGM): blood glucose is measured continuously via the CGM device. This device has been approved for use by the U.S. Food and Drug Administration (FDA).

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 and ≤75 years of age (Upper range to assure dexterity for use of CGM)
* Clinical diagnosis of type 2 diabetes
* HbA1c ≥7.0%
* Diabetes can be treated with any of the following therapies within one month prior to study enrollment: (1) medical nutrition therapy alone or with metformin; (2) sulfonylurea with or without metformin; (3) dipeptidyl peptidase 4 (DPP-4) inhibitor or Glucagon-like peptide-1 (GLP-1) agonist with or without metformin; or insulin with or without metformin.

Exclusion Criteria:

* Treated with Thiazolidinediones (TZD)
* Administered prednisone or cortisone medications in the previous 30 days
* Currently pregnant or planning pregnancy during the study period
* Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
* HbA1c \<7.0%
* Unable to follow the study protocol
* Unable to speak, read and write in English
Real-World Outcomes in Relapsed/Refractory Multiple Myeloma Patients Treated, or Eligible for Treatment, With Idecabtagene Vicleucel

The purpose of this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in France with relapsed/refractory multiple myeloma (RRMM) who are eligible for treatment with, or have been treated with, idecabtagene vicleucel. This study will use both prospective and retrospective data from the DESCAR-T registry database.


Eligibility Criteria:
Inclusion Criteria:

* Patients with RRMM registered in the DESCAR-T registry and eligible for treatment or treated with idecabtagene vicleucel

Exclusion Criteria:

* Not registered with the social security in France
Cannabis Edibles Packaging Descriptors Experiment

The purpose of this study is to assess differences in perceptions of product appeal, harm, and subsequent willingness to try cannabis edibles products with/without product descriptors of interest.

Cannabis edibles are rapidly leading the legal recreational cannabis market. They present health harms that are not typical of smoked marijuana, including accidental overconsumption of high levels of Delta-9-tetrahydrocannabinol (THC). Product packaging plays an important role in influencing perceptions of a product's appeal and potential harm. This experiment will assign participants to view real cannabis edibles packaging edited with one of nine commonly used product descriptors found on real cannabis edibles products, and ask a series of questions to assess perceptions of product appeal and harm. One group of participants will serve as the control and will see the same cannabis edibles packaging without any product descriptors.

Eligibility Criteria:
Inclusion Criteria:

* US resident
* Aged 18-65, inclusive
* Up to 13% of participants will be those who identify as Black/African American
* Up to 16% of participants will be those who identify as Hispanic
* Approximately 50% of participants will be past year cannabis users

Exclusion Criteria:

* Does not currently reside in the United States
* Younger than 18 or older than 65
* Does not provide information regarding history of cannabis use
* Otherwise eligible but demographic and/or user group quotas have been met
Effects of Mechanical Ventilation on the Diaphragm in COVID-19 Intensive Care Patients. A Post-mortem Pathology Study

The diaphragm is the fundamental muscle of the respiratory system. The diaphragmatic dysfunction is present in 60% of critical patients at hospital admission and up to 80% after prolonged mechanical ventilation and difficult weaning.

Risk factors associated with diaphragm dysfunction and atrophy are sepsis, trauma, sedatives, steroids, and muscle relaxants.

The main pathology characteristics of diaphragm biopsies of mechanically ventilated patients are atrophy and a reduction in contractility, determining an impact on the clinical outcome.

Shi et al. found a higher section area of the diaphragm muscle fiber in biopsies of post mortem COVID-19 patients versus negative patients, independently from days of mechanical ventilation.

The hypothesis of our study is to identify different clusters of pathological presentation in post-mortem COVID-19 mechanically ventilated patients.


Eligibility Criteria:
Inclusion Criteria:

* patients deceased in the intensive care unit positive to SARS-CoV-2 and mechanically ventilated
* post-mortem examination of the diaphragm

Exclusion Criteria:

* patients with a terminal disease and a prognosis of less than 48 hours at admission.
Study to Demonstrate the Safety of a Novel Powder Formulation of Lactobacilli in Adults

Lactobacilli are commensal bacteria common to the gut of all mammals studied and traditionally associated with foods are considered safe.The established safe use on a diversity of foods and supplement products worldwide supports this conclusion. Lactobacillus reuteri is one species of Lactobacillus that naturally inhabits the gastrointestinal tract of humans and is one of the few autochthonous (indigenous) Lactobacillus species in infants as well as adults.

Although the tolerability of DSM 17938 in a tablet formulation has earlier been established, it is desirable to repeat the assessment in this novel formulation.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age 18-65 years at visit 1
* BMI 19-29
* Hb ≥ 120 g/l for women and ≥ 130 g/l for men
* Healthy as assessed by the screening laboratory tests and blood pressure determined by the MD
* Signed informed consent and biobank consent

Exclusion Criteria:

* Participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
* Use of oral antibiotics or probiotics during 2 weeks prior to visit 1. Other probiotics other than the study products are not allowed during the study period.
* Pregnant or lactating or wish to become pregnant during the period of the study.
* Lack of suitability for participation in the trial, for any reason, as judged by the personnel at Good Food Practice AB.
Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema

This trial is a randomized, double-blind, two arms, multicenter, Phase III study of Berinert for treatment of ACE induced Angioedema.

This study should show that Berinert shortens the time to complete resolution of signs and symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when given on top of standard treatment. This study should also compare the time to onset of relief as defined by an at least one point reduction on the severity scale of ACE-induced angioedema with Berinert versus placebo.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent to participate in the study and ability to fulfil all study requirements
* Male or female patients aged \>=18 years
* Patients with ACE induced angioedema (grade II-III) with imminent airway obstruction admitted to an Emergency department
* Patient is being treated with ACEi
* Patient must have acute angioedema attack caused by ACEi
* Treatment should be administered within 10 hours after onset of the angioedema
* Patients with angioedema of the head and/or neck (face, lips, cheeks, tongue, soft palate/uvula, pharynx and larynx)
* Male participants and female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country
* Signed patient information consent form

Exclusion Criteria:

* Diagnosis of angioedema of other genesis: e.g. hereditary angioedema, C1-inhibitor deficiency, allergic edema, anaphylaxis, insect bite, trauma, abscess, local inflammation, local tumour, post-operative or post-radiogenic edema, salivary gland disorders
* Participation in a clinical study in the past 30 days
* Patients with simultaneous itchiness of skin (acute urticaria)
* Patients with a history of angioedema before taking ACEi
* History of hypersensitivity to any of the study drugs or medicine with a similar chemical structure.
* Pregnancy and/or breastfeeding
* Mental retardation of the patient with restriction of general judgment and awareness
* History of drug abuse (including alcohol and alcoholic liver disorders)
* Potentially unreliable patients
* Patients who are not suitable for the study in the opinion of the investigator
Italian Translation of the Michigan Hand Outcomes Questionnaire

Patient-Reported Outcome Measures (PROMs) are important clinical items for evaluating injuries and recovery of the hand. Some of the most used Questionnaires, unfortunately, are not available in Italian.

Patient-Reported Outcome Measures (PROMs) are important clinical items for evaluating injuries and recovery of the hand. Some of the most used Questionnaires, unfortunately, are not available in Italian. This poses a problem when evaluating Italian speaking patients. Our aim is to develop a culturally adapted Italian version of the Michigan Hand Questionnaire. There is no risk involved for the patients, as the task of the recruited patients is to answer a survey (online and in clinics).

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* native Italian speakers
* wrist/hand pathology
* trauma (fractures, tendon injuries, etc.)
* chronic pathology, the pathology has been present for at least 1 month (tenosynovitis, chronic arthrosis pain, rheumatic hand or wrist disorders)
* in case of hand/wrist surgery: at least 4 weeks have elapsed since surgery to avoid that the patient could not perform certain actions evaluated by the scale, for example lifting a pan or shopping bags, due to normal post-operative precautions.
* full possession of mental capacity

Exclusion Criteria:

* age \< 18 years
* non-native Italian speakers of Italian, thus also excluding second generation Swiss Italians ("secundo")
* mental incapacity
* upper limb in cast/locked by splint (criterion in Chung's article 98) at the time of the evaluation