cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults

Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.

This is a 52-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period followed by a safety extension phase with crossover or continued treatment to evaluate the efficacy and safety of LYR-210 compared with sham control for treatment in adults with CRS.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Diagnosed as having CRS
* Undergone at least 2 trials of medical treatments in the past
* Mean 3 cardinal symptom (3CS) score
* Bilateral ethmoid disease confirmed on CT
* Has been informed of the nature of the study and provided written informed consent
* Agrees to comply with all study requirements
* If on a waiting list for sinonasal surgery, willing to be removed from list or have surgery date cancelled for the duration of the study.

Exclusion Criteria:

* Inability to tolerate topical anesthesia or endoscopic procedure
* Previous nasal surgery
* Presence of nasal polyp grade 2 or higher
* Seasonal allergic rhinitis
* Perennial rhinitis with symptoms that are well controlled by regular use of intranasal corticosteroids
* Severe asthma
* History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis
* Obstruction preventing proper placement and retention of LYR-210 as seen on endoscopy
* Anatomic variation that, in the opinion of the investigator, would adversely impact placement of LYR-210 as seen on CT
* Known history of hypersensitivity or intolerance to corticosteroids
* Known history of hypothalamic pituitary adrenal axial dysfunction
* Previous pituitary or adrenal surgery
* Dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
* Past or present acute or chronic intracranial or orbital complications of CRS
* History or diagnosis (in either eye) of glaucoma or ocular hypertension
* Past or present functional vision in only 1 eye
* Past, present, or planned organ transplant or chemotherapy with immunosuppression
* Currently positive for COVID-19 or residual sinonasal symptoms from a previous COVID-19 infection
* Pregnant or breast feeding. Females of child-bearing potential must test negative for pregnancy at the time of screening
* Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments
* Currently participating in an investigational drug or device study
* Determined by the investigator as not suitable to be enrolled
Quantitative CT Imaging Parameters for Assessing Hepatic Steatosis in CHB

This study aims to evaluate diagnostic performance of CT attenuation parameters acquired using deep learning algorithm in assessing hepatic steatosis and fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* chronic hepatitis B
* no chronic liver disease other than chronic hepatitis B
* Body mass index \&gt;= 23

Exclusion Criteria:

* pregnant women
* unable to perform MRI examinations due to claustrophobia or metallic foreign body
* suspicious hepatic malignancy on previous imaging studies
* history of local treatment for hepatic lesions
* history of surgery or catheter insertion of liver or spleen
Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout

This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.


Eligibility Criteria:
Inclusion Criteria:

* score over 50 on the 0-100 VAS pain scale
* acute, confirmed gout flare for no longer than 3 days

Exclusion Criteria:

* Treatment with biological anti-tumor necrosis factor (anti-TNF) within the past 3 months
* Anti-inflammatory medication for the treatment of acute gout within the previous 24 hours
* Pregnant or breastfeeding women
* Major surgery with high infection risk
* History of severe allergy to food or drugs
* History or risk of tuberculosis
* Active infection

Other protocol-defined inclusion/exclusion criteria may apply
Effect of Scapular Stabilization Exercises on Scapular Muscles Strength and Kyphosis Index in Smartphone Users

This study will be conducted to investigate the effect of scapular stabilization exercises on scapular muscles strength (serratus anterior, lower fibers of trapezius, rhomboid major and minor), pain intensity level and kyphosis index in different duration of time using daily of smartphone in smartphone users.

Modern people use a smartphone along the day, including occupational and leisure activities. Repeated and prolonged use of smartphones affecting muscular activity and strength around the shoulders and upper back especially serratus anterior during maintaining an un ideal posture which may result in the development of postural changes as excessive thoracic kyphosis which in turn will result in inadequate muscles contractions, weakening of postural muscles and fatigue. Scapular muscles strength should be balanced or integrated (muscle balance) and worked in synchronized motion, so, alteration in scapulothoracic motion in resting position or dynamic motion of scapula described as scapulothoracic dysfunction. Muscle imbalances occurs and lower trapezius, serratus anterior and rhomboids muscles are the most common muscles prone to weakness due to exposure to sustained awkward posture or adaptive postures and restriction to specific activity. Continuous use of smartphone for more than 4 hours daily increases shoulder and parascapular pain, fatigue, decrease strength of scapular muscles (lower fibers of trapezius for scapular adduction and depression and rhomboids for scapular adduction and downward rotation) in right dominant side due to prolonged hyperactivity, then weakness.The excessive use of smartphones correlates with increases incidence of vertebral static disorders, especially kyphosis.

Scapular stabilization exercises were effective in the early rehabilitation and the balance of both sides of the trapezius with the movement and couple motion of the scapula. It is also effective in increasing muscle activation in the serratus anterior and lower trapezius.

Eligibility Criteria:
Inclusion Critria

* Normal subjects from both genders.
* Subjects had to be right hand dominant.
* Age ranged from 17 to 45 years old.
* All subjects had at least 6 months experience in using touch-screen smartphones.
* The mean of smartphone size included in the study will be 5 inches (Mohamed et al., 2020).

Exclusion Criteria:

* Any pain or limitation (dysfunction) at neck and shoulder.
* Any congenital abnormalities in either the cervical or the lumbar spine.
* Previous history of severe surgical procedures.
* Any history of upper extremity injury within the past year.
* Visual problems, dizziness and vertigo.
* Any deformity in the upper extremities or spine.
* Neurological or systemic disorders.
* If they had taken any sedative drug or alcohol within the past 48 hours.
Phenotyping Heterogeneity and Regionality of the Aorta

The aorta distributes cardiac stroke volume into the whole body through its finetuned conductance function, that is propagation and modulation of flow pattern. Physicomechanic properties of the aortic wall assure continuous and homogenous blood flow distribution to organs. The physicomechanic properties of the aortic wall are heterotopic: The collagen/elastin ratio doubles in the abdominal aorta as compared to the thoracic aorta. Malfunction of aortic conduction due to large artery stiffening (LAS) leads to premature wave reflection and excess pulsatility which translate into organ damage in low-resistance beds. The regional heterogeneity of aortic physicomechanic properties and their histomorphological substrate leading to altered regional hemodynamics are not well investigated.

Within the PHaRAo population, there is a spectrum of higher and lower risk patients. The aim of this cohort study is to collect prospectively and systematically clinical research data from PHaRAo patients. This cohort study is an open-end observational study to identify master switches in aortic disease


Eligibility Criteria:
1. apparently healthy volunteers

   Inclusion Criteria:

   • Healthy volunteers

   Exclusion Criteria:
   * \< 18 years
   * Active Medication
   * Cardiovascular Disease
   * MRI not possible
2. Patients with Aortic Stenosis

   Inclusion Criteria:

   • Patients suffering from 3rd drgree Aortic Stenosis

   Exclusion Criteria:
   * \< 18 years
   * MRI not possible
3. Patients with Aortic Aneurysms

Inclusion Criteria:

• Patients suffering from Aortic Aneurysms

Exclusion Criteria:

* \< 18 years
* MRI not possible
Project VerioVue Enhancements - Arterial Study

The aim of this performance evaluation is to compare the blood glucose results obtained using the VerioVue Blood Glucose Monitoring System (BGMS) with those obtained from a validated comparator method (iSTAT 1 Analyser) using arterial blood. The main question the study aims to answer is:

How accurate is the VerioVue BGMS when compared to a product that has already been confirmed as accurate (iSTAT 1 Analyser) when hospital staff test arterial blood on these two types of instrument? Participants will have a small amount of blood taken from an existing arterial line.

Up to two UK NHS hospital sites will be used to collect a minimum of 100 evaluable samples from participants fitted with an arterial line that meet the acceptance criteria. Consent will be obtained from the participants prior to taking part in the study. If the participant meets the enrolment criteria then demographics and medical history information will be collected. A small volume of blood (max 150µl) will be collected from an existing arterial line. The blood will then be applied to six investigational OneTouch VerioVue meters (with expanded haematocrit range 20-65%) fitted with OneTouch Verio test strips and the blood glucose meter readings recorded. Three different lots of test strips will be used in rotation across the study. Within 5 minutes of the last meter test, trained staff will use blood from the same sample and perform a test on the iSTAT Analyser to obtain the blood glucose, haematocrit and oxygen levels of the sample. No treatment decisions will be made based on the blood glucose results obtained for this study. The study documentation will be reviewed by LifeScan monitors for completeness and accuracy and the results entered into a validated database. The data will be extracted and statistically analysed to determine the accuracy of the arterial blood glucose results obtained using the OneTouch VerioVue BGMS when compared to the arterial blood glucose results obtained on the iSTAT 1 Analyser.

Eligibility Criteria:
Inclusion Criteria:

Age - The potential Subject is at least 16 years old. Language - Subject reads and understands English. Informed Consent - The potential subject must read the Participant Information Sheet and sign the Informed Consent Form.

Subject agrees to provide relevant demographic, medical history, and prescription medication information.

The subject agrees to allow study staff access to medical records where necessary.

The Subject agrees to all aspects of the study process, including arterial blood draws performed by an HCP.

Exclusion Criteria:

Age - Subject is under 16 years old. Current Covid-19 positive test result.
A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)

A phase 2, open label, long-term extension study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly.


Eligibility Criteria:
Inclusion Criteria:

1. Completed one of the parent studies (Acrobat Evolve \[CRN00808-02\] or Acrobat Edge \[CRN00808-03\])
2. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
3. Willing to provide signed informed consent

Exclusion Criteria:

1. Clinically significant concomitant disease including, but not limited to, cardiovascular disease; moderate or severe renal insufficiency; or significant liver disease (including cirrhosis)
2. Pituitary radiation since completing participation in parent studies
3. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
4. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab).
5. History of alcohol or substance abuse in the past 12 months
6. Use of any investigational drug (other than paltusotine) within the past 30 days or 5 half-lives, whichever is longer before Screening
7. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study.
8. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
9. Subjects with symptomatic cholelithiasis
10. Subjects with clinically significant abnormal findings during the Screening Period, and any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study
An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)

Primary Objectives:

1. The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis, as measured by change from both baselines in forced vital capacity percent (FVC %) predicted.
2. The primary safety objective is to examine the safety and tolerability of 52 weeks of open-label treatment with HZN-825, inclusive of, but not limited to, adverse events (AEs), serious AEs (SAEs) and the adverse event of special interest (AESI), from Day 1 to 4 weeks after last dose.

This is an open-label, repeat-dose, multicenter extension trial of HZNP-HZN-825-301. Participants who complete the double-blind Treatment Period (Week 52) in Trial HZNP-HZN-825-301 will be eligible to enter this 52-week extension trial. Participants entering this extension trial will complete the Week 52 Visit activities in HZNP-HZN-825-301 and will not complete the Safety Follow-up Visit 4 weeks after the last dose of trial drug in HZNP-HZN-825-301.

Acquired from Horizon in 2024.

Eligibility Criteria:
Key Inclusion Criteria:

1. Completed the double-blind Treatment Period (Week 52) in Trial HZNP-HZN-825-301; participants prematurely discontinued from trial drug in Trial HZNP-HZN-825-301 for reasons other than safety or toxicity can be included at the discretion of the Investigator after completing Trial HZNP-HZN-825-301 scheduled visits, including Week 52 assessments.

Key Exclusion Criteria:

1. Anticipated use of another investigational agent for any condition during the course of the trial.
2. New diagnosis of malignant condition after enrolling in Trial HZNP-HZN-825-301 (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).
3. Women of childbearing potential (WOCBP) or male participants not agreeing to use highly effective method(s) of birth control throughout the trial and for 4 weeks after last dose of trial drug as defined in the protocol.
4. Any new development with the participant's disease or condition or any significant laboratory test abnormality during the course of Trial HZNP-HZN-825-301 that, in the opinion of the Investigator, would potentially put the subject at unacceptable risk.
5. Pregnant or lactating women.
6. Participants will be ineligible if, in the opinion of the Investigator, they are unlikely to comply with the trial protocol or have a concomitant disease or condition that could interfere with the conduct of the trial.
Impact of General Anaesthetics on Excitability of the Peripheral Sensory Nerve

The aim of this study is to investigate the effect of general anaesthetics on nerve excitability. We use the method of threshold tracking to measure selected parameters of nerve excitability.


Eligibility Criteria:
Inclusion criteria: German speaking patients scheduled for surgery under general anaesthesia.

Weight 50 - 100 kg signed informed consent

Exclusion criteria: 1. known peripheral neuropathy 2. Diabetes mellitus 3. Neuro-psychiatric Diagnosis 4. pregnant/ breast-feeding women 5. congestive heart disease 6. more than 2 risk factors (out of 4) for PONV (female, non-smoker, known PONV, opioids postoperatively) 7. participants of other studies 8. inability of verbal expression
MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma

The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response \[PR/CR\]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.

Melanoma accounts for approximately 5% of all skin cancers in the United States, but it accounts for about 75% of all skin cancer deaths. In 2004, the expected prevalence of melanoma is 627,252, with about 119,178 of these cases being Stage III or IV (metastatic melanoma). First line treatments for metastatic melanoma, usually IL-2, dacarbazine and/or temozolomide, are associated with significant toxicities. MDX-010 (anti-CTLA4) antibodies are designed to keep the immune system running by blocking CTLA-4 from down-regulating T cell activation. MDX-1379 is made up of two peptides that are pieces of a bigger melanoma protein (gp100). These peptides bind to HLA-A2 which is then recognized by T cells.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with malignant melanoma
* Measurable unresectable Stage III or IV melanoma
* HLA-A\*0201 positive
* Previous treatment with \& failure/relapse/inability to tolerate IL-2, dacarbazine and/or temozolomide
* At least 4 weeks since prior treatment
* Negative pregnancy
* Life expectancy greater than 4 months
* Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
* Required lab values
* Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) negative

Exclusion Criteria:

* Prior malignancies which the patient has not been disease free for over 5 years, except treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or any other cancer
* Ocular melanoma
* Active, untreated central nervous system (CNS) metastasis
* Prior treatment with MDX-010 (anti-CTLA4) antibody
* Prior treatment with any cancer therapeutic vaccine
* Active autoimmune disease or history of autoimmune disease
* Pregnancy or nursing
* Hypersensitivity to Incomplete Freund's Adjuvant (IFA) (Montanide ISA-51)
* Underlying medical conditions deemed hazardous if treated with study drug
* Concomitant therapy with anti-melanoma drugs, chemotherapies, other investigational therapies, chronic use of systemic corticosteroids
* Unable to provide informed consent
Clinical Study of UTD1 Injection in Combination With Capecitabine in Patients With Advanced and Metastatic Breast Cancer

The purpose of this study is to determine whether UTD1 Injection in combination with capecitabine is effective in the treatment of advanced metastatic breast cancer using capecitabine as a control.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically and/or cytologically diagnosed patients with advanced, metastatic breast cancer,or lacking standard therapy or being failed to or recurrent after standard therapy;
2. Patients who have previously treated with ≤4 chemotherapeutic regimes;
3. Patients who have previously treated with an anthracyclin antibiotics and a taxane;
4. Age 18 -70 years old, ECOG performance status of 0-2; Life expectancy of 3 months or more;
5. Patients with at least 1 measurable target lesion determined by CT within 2 weeks prior to enrollment;
6. Neuropathy \<CTC2 degree （NCI CTC4.03）within 4 weeks prior to enrollment;
7. Basically normal results from routine blood test within 1 week prior to enrollment;
8. Basically normal liver and renal functions within 1 week prior to enrollment;
9. No abnormal function for major internal organs, no heart diseases.

Exclusion Criteria:

1. Received chemotherapy, radiotherapy, therapies with hormones or molecularly targeted drugs 4 weeks prior to enrollment, or received other chemotherapies while participating in this trial;
2. Patients with documented hypersensitivity to Cremophor EL, or patients with previous taxane treatment related SAE;
3. Patients of pregnancy or breast feeding;
4. Patients with previous standard capecitabine treatment ineffective, or patients received standard capecitabine treatment effective, but with less than 6 months of capecitabine clearance period;
5. Patients with uncontrolled brain metastasis or bone metastasis, which plan for recent surgery or local radiotherapy, or other emergency treatment;
6. Patients combined with severe and /or uncontrolled medical conditions, including severe cardiovascular disease, uncontrolled diabetes and high blood pressure, severe infection, severe gastrointestinal ulceration, and patients with incontrollable psychiatric history;
7. Patients with poor compliance;
8. Patients not fitted for this study determined by the investigators.
Effect of Medical Care on Health Status in Acute Kidney Injury

Various forms of organisation in the care of patients with akute kidney injury are investigated.

In this prospective study the investigators compare the effect of usual care with the effect of intensive care. Primary endpoint is the development of cardiovascular events ("major adverse cardiovascular events" "MACE").

The investigators plan to investigate the use of various organisation forms in the care of patients with the diagnosis of acute kidney injury in the hospital. This prospective study compares the effect of usual care with the effect of intensive care in the hospital and outpatient health care center. Primary endpoint is the development of cardiovascular events ("major adverse cardiovascular events" "MACE"). Patients with intensive care receive a nephrology consulting report and extensive information about acute kidney injury and the importance of ambulant follow-up care.

The investigators hypothesise a better in-hospital treatment and an improvement of clinical course in the interventional group.

Eligibility Criteria:
Inclusion Criteria:

* men and women at the age of 18 or older
* acute kidney injury according to KDIGO-guidelines
* The patient (or his/ her authorised representative) is in the position and willing to give informed consent.

Exclusion Criteria:

* Patients, who received kidney transplantation
* Patients on chronic dialysis at the time of enrolment
* Patients who are placed in an institution by judicial or governmental order
* Pregnancy
* Infection with HI- or Infektionen mit HI- oder Hepatitis virus infektion
* Participation in a clinical study with testing on drugs or medical devices (according to German Medicines Law or Medicinal Devices Act)