cyrilzakka/clinical-trials huggingface dataset:
Safety Study for the Treatment of Abdominal Aortic Aneurysms

The primary study objective, at this time, is to follow out to 5 years post implant the safety of already enrolled subjects who were treated with the UniFit Aorto-uni-iliac (AUI) Endoluminal Stent Graft (the "study device") for the repair of abdominal aortic aneurysms (AAAs).

This is a phase II, single-arm, prospective study of the safety of the study device for the repair of AAAs.

The investigator will identify eligible patients and explain the study and study device placement procedure to each patient and/or any available family members. Patients who provide written informed consent will be evaluated for study eligibility within the time period identified under Duration of Treatment. Patients who are confirmed to be eligible, based on screening assessment findings, will be enrolled in the study.

After hospital discharge, patients will attend study center visits at 30 days, 6 months, and 1, 2, 3, 4, and 5 years post-procedure for follow-up evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or older
* Patient has a AAA that meets one of the following criteria:

  1. Aneurysm diameter of greater than 4.5 cm, or less than 4.5 cm with rapid expansion
  2. The aneurysm has a saccular configuration where potential for rupture is increased or has exhibited dissection with potential for rupture at, or compromised flow to, vital structures
* The vessels immediately proximal and distal to the lesion are capable of accommodating the study device
* The access artery diameter and profile of the artery are capable of study device delivery.
* Patient has proximal and distal neck lengths of greater than or equal to 1.0 cm
* Patient is willing and able to comply with the follow-up regime.
* Patient has provided written informed consent.

Exclusion Criteria:

* Patient has an aortic diameter greater than 36 mm.
* Patients with ASA score less than 3 and deemed low risk by the Investigator for open surgical repair.
* Patient has an indispensable inferior mesenteric artery.
* Patient has a distal landing zone of \< 2 cm in length or \> 16 mm in diameter
* Patient has iliac arteries whose tortuosity prevents passage of the introducer catheter.
* If female, patient is pregnant
* Patient has a life expectancy less than two years.
* Patient has an allergy to any of the study device materials
* Patient has coagulopathy or bleeding disorders
* Patient for whom contrast medium or anticoagulation drugs are contraindicated
* Patient has an uncontained rupture of the aneurysm.
* Patient has an active systemic or localized groin infection
* Patient has a connective tissue disease.
* Patient has a GFR \< 30 ml/min/1.73m2
* Patient has a circumferential mural thrombus at the implantation site.
* Patient is a candidate for a bifurcated endovascular graft.
* Patient has an aortic trunk with an angle greater than 90°.
Post Marketing Surveillance (PMS) Study to Assess Safety and Efficacy of Micardis in Patients With Essential Hypertension

The objective of this PMS study was to monitor and assess the safety of Micardis tablets in patients with hypertension over a period of 6 years


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients diagnosed with essential hypertension
* Patients without prior experience with Micardis tablet

Exclusion Criteria:

* Known hypersensitivity to Micardis tablet
* Pregnancy or breastfeeding
* Biliary atresia
* Severe hepatic failure patients
* Severe renal failure patients
Validation of a Smartphone-based Assessment of Movement Health

To correlate a smartphone-based assessment of mobility, stability, and posture with those derived from standard clinical tests among a heterogeneous cohort.

Smartphone movement health assessment introduces a new measure of health that helps users analyze and improve their mobility, stability and posture through performance of movements and physical exercises. To verify the accuracy of this measure, the goal is to provide data-driven evidence regarding its accuracy in comparison to gold standard tests for measuring movement health. To address this challenge, the assessment scores will be benchmarked to a set of gold standard tests and sensor metrics for measuring movement health recommended by professional associations such as the American Physical Therapy Association (APTA) or American College of Sport Medicine (ACSM) and found valid in clinical studies , .

Eligibility Criteria:
Inclusion Criteria:

1. All participants should be able to perform the Smartphone movement health assessment and receive a score for their movement health. This will be evaluated by the research team members during the recruitment process.
2. Ages 18-85 years old
3. Able and willing to give written consent and comply with study procedures

Exclusion Criteria:

1. Pregnant or nursing
2. Skin allergies or irritation that would prevent safe use of sensors described in protocol
A Study of LY3185643 and rGlucagon in Healthy Participants

The purpose of this study is to determine how the body handles LY3185643 and rGlucagon and what effects LY3185643 and rGlucagon have on the body. This study will also help to determine if LY3185643 is safe and well-tolerated.

This study will last at least 35 days, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy as determined by medical history and physical examination
* Body mass index of 18.0 to 30.0 kilograms per square meter (kg/m²)

Exclusion Criteria:

* Have participated, within the last 30 days, in a clinical trial involving an investigational product
* Known allergies to LY3185643 or rGlucagon, related compounds, or any components of the formulation
* History or electrocardiogram (ECG) evidence of heart block, or any abnormality in the 12-lead ECG
* Abnormal blood pressure
* History of recurring symptomatic postural hypotension irrespective of the decrease in blood pressure, or asymptomatic postural hypotension at screening as defined as a decrease in systolic blood pressure greater than or equal to (≥) 20 millimeter of Mercury (mm Hg) within 3 minutes when changing from supine to standing position
* History of vasovagal response such as fainting
* History of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
* History of/current insulinoma and/or pheochromocytoma
* Have used systemic glucocorticoids within 3 months before entry into the study
Height Measurement in Critically Ill Children

Height/length has to be assessed accurately in critically ill children, as its value is required to assess nutritional status, to calculate nutritional requirements, to calculate body surface area (involved in drug prescriptions), and to assess pulmonary function.

The WHO has standardized practices to perform height/length measurements, but this gold standard is not applicable in critically ill children (who cannot stand and are equipped with catheters, tubes and various devices). It is not accurate to rely on previous measurements as children are continuously growing. No height/length measurement tool or method has been validated so far in this population, neither any estimation nor extrapolation methods.

The investigators aim to compare the WHO gold standard for height/length measurement to a list of other methods, validated in other children populations and currently used in the pediatric setting. We intend to compare each of them to the gold standard. The secondary objectives are to describe each height/length extrapolation or estimation method and to estimate the practical use of each method for critically ill children.

A prospective observational study is planned. 140 critically ill children admitted to pediatric intensive care unit (PICU) will be recruited.

Body segments (ulna, tibia, knee-heel, arm span) will be measured and length/height extrapolated from formulas used in different populations. Previous length/height measurements will be collected to draw growth curves and extrapolate actual length/height. Parents will be asked how tall their child is.

After PICU discharge, while the child meets WHO measurement standards, accurate length/height will be measured and compared to the results of the above mentioned techniques.

Comparison will be made in-between these results.


Eligibility Criteria:
Inclusion Criteria:

* age from 28 days to 18 years
* admitted in pediatric intensive care
* WHO standard not applicable
* parent consent

Exclusion criteria:

* expected death before discharge
* expected that the child will not meet in the near future WHO standard criteria to measure height/length
* growth \> 5% height before meeting the WHO criteria
* limb abnormalities, scoliosis, retractions.
Study of Crenolanib for the Treatment of Patients With Advanced GIST With the D842-related Mutations and Deletions in the PDGFRA Gene

This Phase II study is designed to evaluate the antitumor efficacy and pharmacokinetics of crenolanib (CP-868,596) in patients with D842-related mutant metastatic GIST.

Crenolanib (CP-868,596) is an orally bioavailable, selective inhibitor of PDGFR receptor tyrosine kinase with IC50s of 0.4 ng/mL and 0.8 ng/mL for PDGFRα and PDGFRβ, respectively.

In preclinical models of cell lines with the D842V mutation in the PDGFRA gene, crenolanib (CP-868,596) blocked phosphorylation of PDGFRα at nanomolar concentrations, suggesting that it may provide a clinical benefit to patients with D842V mutant GIST.

In addition, crenolanib was also active in inhibiting phosphorylation of cell lines with two point mutations (double mutants) PDGFRA V561D + D842V and PDGFRA T674I + D842V.

Eligibility Criteria:
Inclusion Criteria

* Male or female, of any racial or ethnic group
* Age 18 years or older
* Life expectancy of greater than 12 weeks
* Patient able and willing to provide informed consent
* Normal liver function, defined as AST and ALT ≤2.5x ULN, and Total Bilirubin ≤ 2x ULN.
* Total creatinine ≤ 1.5x ULN
* ECOG Performance Status 0 - 2 (Appendix II)
* Patients must have histologically or cytologically confirmed GIST with a D842-related mutation or deletion on the PDGFRA gene
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan. See Section 10.1.2 for the evaluation of measurable disease.
* Patients must have recovered from any prior therapy and completed the minimum of, either 5 half-lives of prior therapy or 2 weeks must have elapsed since prior treatment

Exclusion Criteria

* Patient unable to provide informed consent
* ECOG Performance status \> 2
* Any concurrent anticancer therapy, immunotherapy, or hormonal therapy.
* Any other investigational agents taken within 2 weeks of start of study drug or if study drug will commence within 5 half-lives of prior therapy
* Patients with known or active Hepatitis B or C; liver cirrhosis.
* Patients with active fungal, viral, and bacterial infections
* Positive serum pregnancy test
* Pregnant or lactating women
* Patients on concomitant medications that induce or inhibit CYP3A4 (Appendix III)
* Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol e.g. impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drugs
Efficacy and Safety of Nokyong Mixture Extract(CME-PI) on Promotion of Immunity

This study was conducted to investigate the efficacy and Safety of Nokyong Mixture Extract(CME-PI) on Promotion of Immunity

This study was a 8 weeks, randomized, double-blind, placebo-controlled human trial. 80 subjects were randomly divided into Nokyong Mixture Extract(CME-PI) group or placebo group. The investigators measured Natural Killer cell activity, Cytokines(IL-2, IL-12, IFN-γ, TNF-α), questionnaire scores of upper airway infection.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women over 50 years
* After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

Exclusion Criteria:

* If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
* Those who received influenza vaccination within 3 months before the screening
* Those who have a body mass index(BMI) of less than 18.5 kg / m\^2 or greater than 35 kg / m\^2 at the screening
* Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic
* Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
* Those who have received antipsychotic medication within 3 months before screening
* Those who alcoholic or drug abuse suspected
* Those who participated in other clinical trials within 3 months before screening
* Laboratory test by show the following results

  * Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
  * Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
Obinutuzumab in Treatment of Fibrillary Glomerulonephritis

The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN).


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Biopsy proven fibrillary glomerulonephritis
* Proteinuria \> 1.0 g/24hrs prior to initiation of immunosuppressive therapy
* eGFR ≥ 20 ml/min/BSA

Exclusion Criteria:

* Secondary FGN (due to monoclonal gammopathy, autoimmune disease or malignancy)
* Presence of a secondary pathology on biopsy (e.g. diabetic nephropathy)
* Hepatitis B, C or HIV positive
* Pregnant or breast-feeding
* Active infection
* Kidney transplant
* Anemia with Hgb \< 8.0 g/dL
* Thrombocytopenia with platelet count \< 100'000
* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication
* Patients who have received cyclophosphamide in the last 6 months
* Patients who have received ACTH and/or mycophenolate mofetil in the last 30 days
* Patient who are on prednisone therapy at a dose \> 10 mg/day in the last 15 days
* Patients who received rituximab previously with CD20 count of \< 5 cells/microliter at the time of enrollment
* For women who are not postmenopausal (greater than or equal to \[\>/=\] 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (\<) 1 percent (%) per year, during the treatment period and for at least 18 months after the last dose of study drug
* For men: agreement to remain abstinent or use two adequate methods for contraception, including at least one method with failure rate of less than 1% per year during the treatment period and for at least 6 months (180 days) after the last dose of drug
A Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement

The purpose of the study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of daily subcutaneous administration of 5 μg/kg tbo-filgrastim in infants, children and adolescents with solid tumors without bone marrow involvement.


Eligibility Criteria:
Inclusion:

1. Male or female infants, children and adolescents aged 1 month to \<16 years.
2. Patients with solid tumors without bone marrow involvement, who are scheduled to receive myelosuppressive CTX.
3. Body weight ≥5 kg.
4. Patients must have an initial diagnosis and histologic proof of their malignancy. All enrolled subjects should have signed consent for a CTX regimen that is known to be myelotoxic, with counts expected to drop below the absolute neutrophil count (ANC) of 0.5 × 109/L for at least 3 days. These regimens would include at least one of the following:

   * Etoposide
   * doxorubicin
   * ifosfamide
   * cyclophosphamide
5. ANC and platelet count: Patients must have an ANC \>1 × 109/L and a platelet count \>100 × 109/L to be eligible for therapy at the start of CTX.
6. Normal cardiac, renal, and hepatic function.
7. All subjects must have a life expectancy of 12 weeks or more.
8. Performance Status: Lansky performance score \>60 (age 1 to \<16 years).

   * More criteria may apply, please contact the investigator for more information.

Exclusion:

1. Bone marrow involvement.
2. Active myelogenous leukemia or history of myelogenous leukemia.
3. Previous treatment with colony-stimulating factors (granulocyte colony-stimulating factor \[G-CSF\], granulocyte-macrophage colony-stimulating factor, interleukin 11 \[IL-11\]) less than 6 weeks prior to study entry.
4. History of congenital neutropenia or cyclic neutropenia.
5. Pregnant or nursing female patients.
6. Fertile patients who do not agree to use highly reliable contraceptive measures Prior bone marrow or stem cell transplant, or prior radiation to ≥25% of bone marrow within the 4 weeks prior to the first tbo-filgrastim dose.
7. Ongoing active infection or history of infectious disease within 2 weeks prior to the screening visit.
8. Treatment with lithium at screening or planned during the study

   * More criteria may apply, please contact the investigator for more information.
Impact of Equestrian Sports, CrossFit, and Gym Training on Pelvic Floor Health (PELFISPORT )

This observational cross-sectional study investigates the impact of equestrian sports, CrossFit, and gym training on pelvic floor health in both athletes and non-athletes. The study aims to determine whether specific sports are associated with a higher risk of pelvic floor dysfunction, including urinary incontinence, pelvic organ prolapse, and chronic pelvic pain.

Participants will complete an online survey that collects demographic information, sports participation details, and pelvic floor health symptoms. The survey includes standardized questionnaires to assess pelvic floor function. Data will be analyzed to compare the prevalence of pelvic floor issues among different sports and between athletes and non-athletes.

The study seeks to provide insights into how sports participation influences pelvic health and to raise awareness of pelvic floor dysfunction in both male and female athletes.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years or older.
* Voluntary participation with signed informed consent.
* Completion of the online survey.
* For the sports groups (Equestrian, CrossFit, Gym, Other Sports):

  * Minimum 2 years of experience in the sport.
  * Minimum 2 training sessions per week.

Exclusion Criteria:

* Individuals under 18 years old.
* Participants who do not complete the survey.
* Individuals with neurological conditions affecting mobility.
* Individuals with mobility impairments unrelated to sports.
* Sports participants with less than 2 years of experience or training less than twice per week.
3D Echocardiographic Assessment of RV Function in Patients Undergoing Pulmonary Endarterectomy

Chronic thromboembolic pulmonary hypertension causes progressive right heart hypertrophy, dilatation and dysfunction. Surgical treatment is pulmonary endarterectomy, which although only carried out in a single UK centre, provides an excellent model for assessing right ventricular function. Right heart function is most commonly assessed using echocardiography, either transthoracic pre- and post-operatively, or transoesophageal intra-operatively. Measurement of tricuspid annular plane systolic excursion is the best validated and most commonly performed measurement for right heart function, however it may be inaccurate after sternotomy and pericardial opening, making accurate assessment difficult immediately after surgery. Therefore, we aim to compare established methods of assessing right heart function with 3-dimensional echocardiographic reconstruction of the ventricle, using a novel reconstruction mechanism. Right ventricular function will be assessed in 51 patients who undergo pulmonary endarterectomy surgery at baseline, after the pericardium has been opened, following the surgical procedure, using transoesophageal echocardiography, and at six-month outpatient followup using transthoracic echocardiography, as 3D-reconstruction is valid using both modalities. This comparison should allow the investigators to determine whether such a method could replace current measurement parameters for assessment of right ventricular function, which is important for clinical management of patients in a variety of settings.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* undergoing pulmonary endarterectomy surgery at Papworth Hospital
* Willing to provide informed consent

Exclusion Criteria:

* Patient refusal
* Contraindication to transoesophageal echocardiography
* Technical difficulty preventing adequate echocardiographic assessment of right heart function