cyrilzakka/clinical-trials huggingface dataset:
Trial of JYB1904 in Chronic Spontaneous Urticaria.

This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adult subjects (≥18 years of age).
* Diagnosis of Chronic Spontaneous Urticaria(CSU) ≥ 3 months prior to Screening Visit 1 and previously inadequately controlled with a second-generation H1 antihistamine.
* Itching and hives lasting ≥ 6 weeks prior to Screening Visit 1.
* Have a UAS7 (range 0 - 42) ≥ 16, an ISS7 (range 0 - 21) ≥ 6, and an HSS7 (range 0 - 21) ≥ 6 within 7 days prior to randomization.

Exclusion Criteria:

* Induced urticaria with a defined trigger, including artificial urticaria (cutaneous scratches), cold-contact, heat-contact, solar, pressure, delayed-pressure, water-source, cholinergic, or contact urticaria
* Any other dermatological condition with chronic itching, such as atopic dermatitis, herpetic pemphigoid, herpetic dermatitis, senile itching, or psoriasis, which in the opinion of the investigator may affect the study assessment and study results
* Other conditions with symptoms of urticaria or angioedema, including but not limited to urticarial vasculitis, pigmented urticaria, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticaria.
* Previous allergic reaction or poor efficacy with omalizumab.
* Contraindication or hypersensitivity to antihistamines (e.g., fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, bilastine) or any of the ingredients.
A Study of ATH-1017 in Mild to Moderate Alzheimer's Disease

This study is designed to evaluate treatment effects of ATH-1017 (fosgonimeton) in mild to moderate Alzheimer's subjects with a randomized treatment duration of 26-weeks.

This study is designed to assess the correlation of the functional translational biomarker P300 latency and change in ADAS-Cog11 induced by ATH-1017 therapy, over 26-week randomized, double-blind treatment.

Eligibility Criteria:
Key Inclusion Criteria:

* Age 55 to 85 years
* Mild-to-moderate AD dementia subjects, MMSE 14-24, CDR 1 or 2 at Screening
* Clinical diagnosis of dementia, due probably to AD, by Revised National Institute on Aging-Alzheimer's Association criteria (McKhann, 2011)
* Reliable and capable support person/caregiver
* Treatment-free or receiving stable acetylcholinesterase inhibitor (AChEI) treatment, defined as:

  * Treatment-naïve, OR
  * Subjects are on a stable, approved dose of an AChEI (except for donepezil at 23 mg PO) for at least 3 months before Screening OR
  * Subjects who received an AChEI in the past and discontinued 4 weeks prior to Screening

Key Exclusion Criteria:

* History of significant neurologic disease, other than AD, that may affect cognition, or concurrent with the onset of dementia
* History of unexplained loss of consciousness, and epileptic fits (unless febrile)
* Subject has atypical variant presentation of AD, if known from medical history, particularly non-amnestic AD
* History of brain MRI scan indicative of any other significant abnormality
* Hearing test result considered unacceptable for auditory ERP P300 assessment
* Diagnosis of severe major depressive disorder even without psychotic features
* Significant suicide risk
* History within 2 years of Screening, or current diagnosis of psychosis
* Myocardial infarction or unstable angina within the last 6 months
* Clinically significant (in the judgment of the investigator) cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)
* Subject has either hypertension (supine diastolic blood pressure \> 95 mmHg), or symptomatic hypotension in the judgment of the investigator
* Clinically significant ECG abnormality at Screening
* Renal insufficiency (serum creatinine \> 2.0 mg/dL)
* Hepatic impairment with alanine aminotransferase or aspartate aminotransferase \> 2 times the upper limit of normal, or Child-Pugh class B and C
* Malignant tumor within 3 years before Screening
* Memantine in any form, combination or dosage within 4 weeks prior to Screening
* Donepezil at 23 mg PO
* The subject has received active amyloid or tau immunization (i.e., vaccination for Alzheimer's disease) at any time, or passive immunization (i.e., monoclonal antibodies for Alzheimer's disease) within 6 months of Screening
Open Pilot Trial Evaluating an Avatar-Guided Intervention for Emerging Adults With Alcohol Use Problems and Suicide Risk

This study is an open pilot usability trial to test the 1) usability of a newly developed mobile health intervention to help manage suicidal ideation and alcohol use problems and 2) feasibility of research protocols with emerging adults (18-29 year-olds) who present to the emergency department.

This study is an open pilot usability trial with emerging adults presenting to the emergency department with binge drinking and suicidal thoughts. The main study aims are to test the usability of a newly developed avatar-guided mobile health intervention and feasibility of 28 days of daily assessments and four follow-ups at 4-, 8-, and 12-weeks after discharge.

Ten emerging adults aged 18-29 years old will be recruited from the emergency department who have suicidal ideation and alcohol use problems. Exclusion criteria are conditions that would preclude research participation (e.g., cognitive disabilities, in police custody; at imminent risk of harming oneself in the emergency department).

All ten participants will be given access to a newly designed avatar-guided digital intervention and text message intervention (EA-Avatar) for 12 weeks in addition to usual emergency department care. Participants will complete measures of alcohol use, suicidal ideation, and alcohol-related cognitions and experiences, as well as service utilization. They will also complete a scale of usability of the avatar intervention and qualitative interviews of the intervention and research protocols.

Based on participant qualitative interviews, a scale of usability of the digital intervention, feedback surveys, recruitment and retention in the study, participant completion of daily diary and ecological assessment surveys, and analysis of mobile intervention usage data, the intervention will be revised, before testing in a larger randomized controlled feasibility trial.

Eligibility Criteria:
Inclusion Criteria:

* Emergency department admission for alcohol- or suicide-related reason
* aged 18-29
* speak, read, and understand English
* binge drinking and alcohol use problems in the past month
* active suicidal ideation in the past month
* owning and having access to a personal smartphone

Exclusion Criteria:

* severe cognitive delay, active psychosis, or heavy intoxication that precludes research participation
* at imminent safety risk and need to be on a 1:1 observation, in which case research may interfere with their clinical care in the emergency department
* under arrest or a prisoner/inmate
* not interested or are unwilling to use an avatar-guided digital intervention
Short- and Long-term Outcomes of Stenting for Symptomatic Intracranial Arterial Stenosis: a Cohort Study

The purpose of this study is to assess short and long term outcomes of stenting for symptomatic intracranial arterial stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Participants had a symptomatic intracranial stenosis of 70-99 percentage (%) with a lesion length of ≤15 mm and target vessel diameter of ≥2.0 mm in the intracranial internal carotid, middle cerebral, intracranial vertebral or basilar arteries and the measurements of stenosis will be made on magnetic resonance angiography (MRA) using the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial method and confirmed by digital subtraction angiography (DSA).
* Presented with transient ischemic attack (TIA) or stroke within the past 12 months attributed to the stenosis.

Exclusion Criteria:

* Participants with acute infarctions within the past 3 weeks.
* Severe arterial tortuosity prevents the deployment of endovascular devices.
* Non-atherosclerotic lesion on magnetic resonance imaging (MRI), embolic or perforator stroke on MRI or computerized tomography (CT).
* A baseline modified Rankin Scale (mRS) score of \>3.
* Massive cerebral infarction (\>1/2 middle cerebral artery (MCA) territory), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor on CT or MRI scan.
Study of a Probiotic Strain to Prevent Mastitis and to Eradicate GBS Colonization

In previous studies, the investigators have seen that carefully-selected Lactobacillus strains are a good alternative to antibiotics for the treatment of lactational mastitis. The objective of this new study is to check if they can also have a preventive role when administered to women with a history of mastitis with one or more previous infants. Since the investigators have also realized that peripartum antibiotherapy (mainly GBS-targeting intrapartum prophylaxis)is a predisposing factor for mastitis (because of the selection of resistant bacteria), the investigators would also like to test if administration of the strains to GBS-colonized pregnant women may lead to GBS eradication. Therefore, a mastitis-predisposing factor would de avoid.


Eligibility Criteria:
Inclusion Criteria:

* Normal pregnancy
* Healthy women
* Lactational mastitis in, at least, a previous lactation period
* No symptomatic vaginal infections

Exclusion Criteria:

* Any kind of health problems related to pregnancy
* Symptomatic vaginal infections
* Allergy to cow's milk protein
* Intolerance to lactose
* Antibiotic treatment
Research on Anxiety and Depression: Computer-Assisted Therapy

This study examines how online self-guided programs can improve mood and anxiety symptoms. These programs use exercises from Cognitive-Behavioral Therapy, which is an evidence-based treatment for depression and anxiety. The purpose of this study is to learn who will do best with the online format. Our aim is to learn for whom online self-guided interventions are most efficacious. This knowledge is important because it will help inform clinicians and patients about who might benefit from this type of intervention versus who would need the assistance of a therapist. More specifically, we hope to figure out who would benefit from solely an online intervention and who would benefit from an online intervention in addition to other treatment.


Eligibility Criteria:
Inclusion Criteria:

* Previous participation in the RAD study in our laboratory

RAD study inclusion criteria are:

* 18+ years of age
* Fluent and literate in English
* Can provide informed consent
* fMRI scanning eligibility, including no evidence of any form of metal embedded in the body (e.g., metal wires, nuts, bolts, screws, plates, sutures)

Exclusion Criteria:

* Anyone who has not already completed the RAD study will be excluded.

RAD study exclusion criteria are:

* Presence of suicidal ideations representing imminent risk
* General medical condition, disease, or neurological disorder that interferes with the assessments
* Mild traumatic brain injury (history of physical brain injury or blow to the head resulting in loss of consciousness greater than five minutes) and which could interfere with doing the assessments
* Severe impediment to vision, hearing and/or hand movement, likely to interfere with ability to complete the assessments
* Unable and/or unlikely to follow the study protocols
* Pregnant or breastfeeding
Residual Symptoms and the Quality of Life in Individuals Recovered From COVID-19 Infection: A Survey From Pakistan

There remains scarcity of literature regarding the patient's health status post-COVID-19 infection. This study analyzes the prevalence of residual symptoms and quality of life (QoL) after COVID-19.

An anonymous online survey was administrated in Pakistan from November 2020 to April 2021 in COVID-19 survivors. The questionnaire used the 12-Item Short Form Health Survey (SF-12) to assess mental and physical QoL. Multivariate linear regression was used to explore factors associated with mental and physical QoL scores.

A total of 331 COVID-19 survivors participated in our survey. Around 42.0% of the cohort reported within 1-3 months of diagnosis of COVID-19. The common residual symptoms were body aches (39.9%), low mood (32.6%), and cough (30.2%). Better physical QoL was associated with being male (adjusted beta: 3.328) and having no residual symptoms (6.955). However, suffering from nausea/vomiting during initial COVID-19 infection (-4.026), being admitted to the ICU during COVID-19 infection (-9.164), and suffering from residual body aches (-5.209) and low mood (-2.959) was associated with poorer QoL. Better mental QoL was associated with being asymptomatic during initial COVID-19 infection (6.149) and post-COVID (6.685), while experiencing low mood post-COVID was associated with poorer mental QoL (-8.253 \[-10.914, -5.592\]).

Despite presumed "recovery" from COVID-19, patients still face a wide range of residual symptoms months after initial infection, which contributes towards poorer QoL. Healthcare professionals must remain alert to the long-lasting effects of COVID-19 infection and aim to address them appropriately to improve patients' QoL.

Eligibility Criteria:
Inclusion Criteria:

* Tested negative for COVID-19 when enrolled in the study
* COVID-19 negative for at least 6 months

Exclusion Criteria:

* Still Positive for COVID-19 tested one week ago
* COVID-19 negative for less than 6 months
Solid Tumors Using Ixabepilone and Dasatinib

Patients are being asked to take part in this study because they have been diagnosed with an advanced solid tumor that is not responding to standard treatments. This study will find the highest dose of ixabepilone and dasatinib in combination that can be given without causing severe side effects.

Both ixabepilone and dasatinib have individually been tested in many (several thousand) patients, however the combination of the two drugs has not yet been tested in humans.

All patients who will take part in this study will receive combined drug therapy of dasatinib and ixabepilone. Dasatinib is a pill that is taken by mouth. Ixabepilone is a medicine that will be given by vein (IV).

All participants will receive ixabepilone by vein once every three weeks as well as dasatinib by mouth once daily.


Eligibility Criteria:
Inclusion Criteria:

* Have a solid tumor malignancy that is metastatic or locally advanced/unresectable
* Progression through standard therapy
* Histological documentation of cancer
* Must be off prior chemotherapy or radiation therapy for at least 3 weeks
* Must have adequate organ and marrow function prior to the start of study treatment as defined by the protocol
* Must be able to swallow oral medication (dasatinib must be swallowed whole)
* Must be available for protocol-required follow-up

Exclusion Criteria:

* Patients with a malignancy (other than the one treated in this study) which required radiotherapy or systemic therapy within the past 5 years
* Symptomatic brain metastasis that is either untreated or uncontrolled by surgery and or radiotherapy
* A known, prior, severe (NCI CTC Grade 3/Grade 4) history of hypersensitivity reaction to a drug formulated in Cremophor (polyoxyethylated castor oil)
* A serious, uncontrolled medical disorder or active infection including pericardial or pleural effusion of any grade,uncontrolled or significant cardiovascular disease,a bleeding disorder.
Flexi-Bar and Multi-Component Exercises

Background: Previous studies have suggested that both Flexi-Bar and Multi-Component exercises can improve an individual's physical fitness and musculoskeletal discomfort. However, determining which is more effective in enhancing the frailty, physical fitness, and musculoskeletal discomfort of the elderly remains controversial.

Objective: This study aims to investigate differences in the effectiveness of Flexi-Bar and Multi-Component exercises in improving the frailty, physical fitness, and musculoskeletal discomfort of the elderly after 12 weeks of intervention.

Methods: A single-blind randomized controlled trial was conducted to collect data from a city in central Taiwan. Participants were randomly divided into a Flexi-Bar group (FB group) and a Multi-Component exercise group (MCE group). Participants in the FB group performed a 60-minute Flexi-Bar exercise every week for 12 consecutive weeks. Meanwhile, Participants in the MCE group performed a 60-minute Multi-Component exercise every week for 12 consecutive weeks. Tests were conducted both before and after the 12-week intervention using items including the Kihon Checklist, Senior Fitness Test, and Nordic Musculoskeletal Questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* (1) participants aged 65 years and over;
* (2) participants who could communicate in Mandarin or Taiwanese and cooperate with sports activities; and
* (3) participants who could walk independently without assistance (or with aid).

Exclusion Criteria:

* (1) participants with unstable physiological conditions (or those who were recommended against participating in physical activities by their doctor);
* (2) participants with unstable mental conditions; and
* (3) participants who could not complete the 12-week exercise intervention.
IVC and Lung Ultrasound B-lines Guided Decongestion in Critically Ill ESKD Patients With Heart Failure

The objectives of this trial are to determine whether, in critically ill ESKD patients randomization to fluid removal guided by lung and inferior vena cava ultrasound, compared to standard care, leads to Improved pulmonary congestion (primary outcome); and safety (secondary outcome) in the short-term.

The point-of-care ultrasound was thought useful in the management of fluid in critically ill patients. At present, the role of the lung and inferior vena cava ultrasound is unclear in the management of decongestion of heart failure in kidney failure (KF) patients using prolonged hemodialysis. The investigators aim to explore the effect of pre-dialysis probing with the lung and inferior vena cava to guide fluid removal as compared with conventional protocols on the improvement of heart failure symptoms in patients with KF with heart failure under prolonged hemodialysis in the short-term.

Eligibility Criteria:
Inclusion Criteria:

1. patients meet the diagnostic criteria for end-stage renal disease;
2. indications that the patient may be experiencing signs and/or symptoms of heart failure, and based on the serum N-terminal pro-brain natriuretic peptide level of greater than 11,215. 2 ng/L;
3. patients may require prolonged intermittent renal replacement therapy due to volume overload;
4. patients ≥18 yo and ≤80 yo;
5. either the patient or a family member signs the informed consent;
6. patients will undergo at least two sessions of prolonged hemodialysis.

Exclusion Criteria:

1. history of malignancy or psychiatric disease;
2. patients with a history of congenital heart disease or hypertrophic cardiomyopathy;
3. coagulation abnormalities, intracranial, visceral or gastrointestinal bleeding in the past 3 months, or contraindications to heparin anticoagulation;
4. The duration of prolonged hemodialysis \<8 hours;
5. Ultrasound unable to monitor the inferior vena cava, or can't access the date;
6. Pregnancy;
7. Patients with severe respiratory failure;
8. Patients with combined severe infections, such as patients with sepsis;
9. Presence of pre-dialysis hypotension: systolic blood pressure \<90 mmHg;
10. other conditions deemed ineligible by physicians.
A Study of Continuous Blood Pressure Monitoring in Healthy Participants

The main purpose of this study in healthy participants is to find out whether the traditional ambulatory blood pressure monitor (ABPM) and newer wearable devices (EmbracePlus smartwatch device, Biobeat chest patch device, and Aktiia wrist device) will accurately pick up changes in blood pressure caused by 2 different medications (propranolol and pseudoephedrine). The study will last about 29 days excluding the screening period of 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females
* Have a body mass index (BMI) of 18.0 to 35 kilograms/square meter (kg/m2), inclusive at screening
* Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
* Have given written informed consent approved by Lilly and the ethical review board governing the site

Exclusion Criteria:

* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Have history of sensitive skin or chronic skin conditions, like eczema
* Regular use of known drugs of abuse
* Are women who are pregnant or lactating
* Have known allergies to medications used in the study
Study Evaluating DVS-233 in Adult Outpatients With Major Depressive Disorder

Primary: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.

Secondary: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general well-being, pain, and remission (Hamilton Psychiatric Rating Scale for Depression, 17-item \[HAM-D\<sub\>17\</sub\>\] \< 7) versus those subjects receiving placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a primary diagnosis of major depressive disorder (MDD)
* Depressive symptoms for at least 30 days prior to the screening visit
* Minimum screening and study day -1 (baseline) scores of 20 on the Hamilton Psychiatric Rating Scale for Depression (HAM D\<sub\>17\</sub\>)

Exclusion Criteria:

* Treatment with DVS-233 SR at any time in the past
* Treatment with venlafaxine (immediate release \[IR\] or extended release \[ER\]) within 90 days of study day 1
* Known hypersensitivity to venlafaxine (IR or ER)
A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

This is a randomized, controlled, examiner-blind, parallel group, four week clinical study comparing brushing plus flossing to brushing alone in healthy adults with mild-to-moderate gingivitis.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age;
* physically able to floss his/her teeth;
* refrained from performing oral hygiene the morning of the Baseline visit;
* have measurable gingivitis on at least 5 test sites;
* in good general health.

Exclusion Criteria:

* severe periodontal disease
* atypical discoloration or pigmentation in the gingival tissue;
* meaningful malocclusion of the anterior teeth;
* fixed facial orthodontic appliances;
* use of antibiotics within two weeks of the baseline visit and at any time during the study;
* any diseases or conditions that could be expected to interfere with the subject safely completing the study.