cyrilzakka/clinical-trials huggingface dataset:
Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia

The purpose of this study is to compare Posoleucel (formerly known as ALVR105; Viralym-M) to placebo in kidney transplant recipients who have high or low levels of BK virus in their blood.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had a kidney transplant performed greater than or equal to 28 days prior to enrollment
* At least 1 identified, suitably matched Posoleucel (ALVR105) cell line for infusion is available.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

* Undergone allogeneic hematopoietic cell transplantation
* Evidence or history of graft versus host disease (GVHD) or cytokine release syndrome (CRS).
* Uncontrolled or progressive bacterial or fungal infections
* Known or presumed pneumonia
* Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose \>0.5 mg/kg/day or equivalent).
* Pregnant or lactating or planning to become pregnant.
* Weight \<40 kg.
* Patients who received, or planned to receive abatacept or belatacept, within 3 months of screening
39946-I Laser and Bevacizumab Treatment for Retinopathy of Prematurity

Retinopathy of prematurity (ROP) is a leading cause of childhood blindness. Vascular endothelium growth factor (VEGF) is an important component of this disease. The goal of treatment is to reduce the production of VEGF in the immature retina and to eliminate the abnormal growth of new vessels. Currently, laser photocoagulation of the peripheral avascular retina is the treatment standard. Intravitreal injection of anti-VEGF antibody Bevacizumab (IVB) has been used clinically off-label as an alternative therapy. However, VEGF is important for the development of neurons and vessels in the systemic organs in premature infants. Pharmaceutical study showed that IVB was absorbed into the bloodstream. It is unclear if the systemic absorption of Bevacizumab is dose related, and the short and longterm effects on ocular and systemic systems, especially neurological development. In this study, our goals are to establish the pharmacokinetics of Bevacizumab in the premature infant and to compare the short and long-term vision and neurodevelopmental outcomes of infants treated with IVB compared to laser ROP.

This study will enroll preterm infants who were scheduled to receive treatment for ROP by laser or Bevacizumab. We will observe the patients in the hospital for the cure of ROP until 54 weeks' postmenstrual age. We will check the changes of chemicals in the blood and observe short-term and long-term effects on visual system, brain and other body organs. Descriptive statistics from a two sample t-test or Fisher's exact test will be used to compare the short and long-term vision and neurological development outcomes. We predefined a statistical significance level p=0.05.

Eligibility Criteria:
Inclusion Criteria:

Premature infants who were scheduled to receive laser or BEvacizumab treatment for type I ROP .

Exclusion Criteria:

1. Have unilateral or Bilateral ROP Stage 4 or 5 ROP;
2. Lack of signed consent by the parent or legal guardian.
Rosuvastatin and Evolocumab for Coronary Artery Disease

The aim of the retrospective study is to characterize the molecular mechanisms responsible for the effect of statins and evolocumab in patients with stable coronary artery disease. The research team will retrieve and review intravascular imaging and gene expression data previously collected in the catheterization laboratory during the following time-period: 8/1/2013-4/14/2015 and 5/4/2021 - 10/28/2022.

The researchers will use the previously collected transcriptomic and intravascular imaging data collected from subjects between 8/1/2013-4/14/2015 (statin group) and subjects who participated in YELLOW III study (evolocumab group). The analyses will allow us detect common and unique pathways for each drug. The researchers will use intravascular imaging findings (optical coherence tomography, OCT) to characterize patient's individual response to treatment as beneficial, if OCT fibrous cap thickness (FCT) increased at follow-up and develop machine-learning models to predict the individual response using baseline gene expression.

The researchers hypothesize that the analyses will uncover unique gene panels predicting beneficial response to statin and evolocumab allowing to select the best treatment approach for an individual patient. The total number of subjects will be 195. Transcriptomic profile of PBMC at baseline and follow-up will be compared between the groups to establish the common and distinctive molecular mechanisms of the effect of statins and evolocumab.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with coronary artery disease who underwent cardiac catheterization with or without PCI
* Patients from 8/1/2013-4/14/2015 and YELLOW III with both visits available, baseline and follow-up

Exclusion Criteria:

* patients from 8/1/2013-4/14/2015 and YELLOW III lost to follow-up
Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer

The purpose of this study is to determine if trans-rectal microwave ablation of the index tumor of patients with low-risk prostate cancer is sufficiently precise and safe, using MRI-transrectal ultrasound image registration.

In men with low-risk prostate cancer, European and American guidelines recommend either active surveillance or whole-gland treatments, with significant induced morbidity and burden on quality of life. Focal treatments of the index tumor are currently under investigation to decrease morbidity while proposing active treatment.

The purpose of this study is to determine the feasibility, precision and safety of a novel ablation treatment using microwaves, delivered transrectally under real-time guidance with MRI-transrectal ultrasound image registration. The index tumor will be detected with prostate MRI and characterized with targeted biopsies using MRI-transrectal ultrasound image registration. It will then be ablated with microwaves using the same transrectal approach and guidance system (KOELIS).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 45 to 76 years old ;
* Life expectancy above 10 years ;
* Diagnosis of prostate cancer confirmed on prostate biopsies ;
* Low risk of progression, defined with D'Amico criteria :

  * T1c or T2a stage
  * Maximum Gleason score of 3+4, including targeted biopsies corresponding to less than 50% grade 4 for the tumor
  * Prostate Specific Antigen \<15 ng/mL
* Detection of the index tumor with prostate MRI, characterized with targeted biopsies using MRI-transrectal ultrasound image registration ;
* Patient accepting to be followed after the procedure using active surveillance protocol standards ;
* Patient affiliated to national health care insurance ;
* Free consent, informed and written, dated and signed by the patient and the investigator before enrollment.

Exclusion Criteria:

* Medical past history of prostatic surgery ;
* Medical past history of radiotherapy or pelvic trauma ;
* Medical past history of acute or chronic prostatitis
* severe BPH-related urinary tract symptoms defined as an IPSS \>18 ;
* Extra-capsular extension or seminal vesicle invasion on prostate MRI.
* Tumor involvement \> 3 mm on systematic biopsies outside the tumor volume detected on MRI.
* Tumor largest axis \> 20 mm on prostate MRI ;
* Distance of less than 5 mm between the tumor and the rectum
* Patient unable to understand the course of the study
* History of allergy or non-tolerance to gadolinium salts used in MRI
* Patient with a contraindication to performing an MRI
* Person placed under safeguard of justice
How Respiratory Pathogens Panel Results Affect Patients' Plan of Care

Reviewing providers' current standard operating procedure on Respiratory Pathogen testing

The general design of this study is collecting data and reviewing Principal Investigators' Standard Operating Procedures on Respiratory Pathogen testing and changes made to their specific SOP.

Eligibility Criteria:
Inclusion Criteria:

* Must be a Medical Practitioner

  * Medical Doctor (MD)
  * Doctor of Osteopathic (DO)
  * Physician Assistant (PA)
  * Advanced Practice Registered Nurse (APRN)
  * Nurse Practioner (NP)
* Must have a current standard operating procedure that includes obtaining/reviewing medical history.

Exclusion Criteria:

* Government-funded insurance data cannot be included in the study.
Pharmacokinetics and Pharmacodynamics of BIWH 3 in Healthy Duffy Positive vs. Duffy Negative Male Volunteers

Study to compare the pharmacokinetic and pharmacodynamic effects of escalating dosages of recombinant human pyro-Glu MCP-1 (BIWH 3) in Duffy positive vs. Duffy negative healthy male volunteers: plasma levels of monocyte chemotactic protein-1 (MCP-1) and markers of leukocyte, coagulation, platelet and endothelial activation will be quantified; To examine the safety of BIWH 3 in this setting


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Erythrocyte Fy positive and negative individuals because expression of the Duffy (Fy) receptor may influence MCP-1 plasma levels in humans
* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age ≥ 18 and ≤ 50 years
* Body mass index: ≥18 kg/m2 and \< 30 kg/m2
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory variables unless the investigator considers an abnormality to be clinically irrelevant
* Normal pharmacodynamic variables as determined at baseline visit
* Normal response to glucose tolerance test

Exclusion Criteria:

* Any finding in the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Current or history of: gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, autoimmune, hormonal disorders, diseases of the central nervous system (such as epilepsy), psychiatric disorders or cancer
* Symptoms of a clinically relevant illness in the 3 weeks prior to planned administration of study drug
* History of orthostatic hypotension, fainting spells and blackouts
* Chronic or relevant acute infections
* History of allergy / hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Any Electrocardiogram (ECG) value outside the reference range of clinical relevance including, but not limited to QRS interval \> 110 ms or QTcB \> 450 ms
* Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to planned administration of study drug
* Use of any drugs which might influence the results of the trial within 10 days prior to planned administration or during the trial
* Participation in another trial with an investigational drug within 2 months prior to planned administration or during trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Current or history of drug, alcohol, tobacco or caffeine abuse
* Blood donation within 1 month prior to planned administration or during the trial
* Excessive physical activities within 5 days prior to planned administration of study drug or during the trial
* Seropositivity for hepatitis B antigen (HBs-Ag), hepatitis C (HCV), HIV 1, or HIV 2 antibodies
* Weight over 95 kg
Teleassessment in Neck Pain

New technologies have improved the aproach of patients with different pathologies. Neck pain is a prevalent pathology in physical therapy clinics. Evaluating patients with an electronical device could decrease the services saturation and the proffesionals overload.


Eligibility Criteria:
Inclusion Criteria:

* Presence of neck pain
* Between 18 and 65 years
* Accepted to sign the informed consent

Exclusion Criteria:

* Cognitive impairment.
* Traumatic accidents.
* Other orthopedic or neurologic pathology.
High Tibial Osteotomy for Osteoarthritis of the Knee

A prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu plate. The clinical outcome and radiological results were examined at one year.

A prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu plate. The clinical outcome and radiological results were examined at one year.

The primary outcome measure was the achievement of an overcorrection of valgus of 4°. Secondary outcome measures were the severity of pain (visual analogue scale), knee function (Hospital for Special Surgery score), and walking distance.

Eligibility Criteria:
Inclusion Criteria:

* Radiological OA, medial joint pain and varus malalignment

Exclusion Criteria:

* Symptomatic OA of the lateral compartment, rheumatoid arthritis, ROM \<100, collateral ligament laxity, history of fracture of previous open operation of the lower limb and a flexion contracture \> 10 degrees.
Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic Subjects

This study is a multi-center, open-label comparison study and aimed to evaluate the preliminary performance of this 13C-uracil GEBT to examine its abilities of identifying abnormal (delayed) gastric emptying rates in subjects.

Approximately equal numbers of subjects will be enrolled in each of the 2 groups (with normal gastric emptying, and with delayed gastric emptying (gastroparesis)) to complete at least 10 subjects per group.

The subjects will first have their gastric emptying rates investigated by scintigraphy using the Solid Test Meal containing 500 uCi 99mTc sulfur colloid at Visit 1. Second, the subjects will have their gastric emptying rates investigated by scintigraphy and 13C-uracil GEBT simultaneously using the Semi solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100 mg of 13C-uracil, respectively, at Visit 2. A comparison will be made between the results obtained at Visits 1 and 2 along with a comparison of the data obtained during Visit 2 for evaluation of the 13C-uracil GEBT.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index \[range is 18.0 to 33.0 kg/m2
* Subjects with any upper GI symptoms
* Stable creatinine

Exclusion Criteria:

* History of known peptic ulcers or stomach cancer.
* History of stomach surgery or resection
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food or other substance, unless approved by the investigator
* History of alcoholism or drug abuse
* History or presence of clinically significant GI, cardiovascular, central nervous system, hepatic, or renal disease; or other conditions
* History of eating disorders
* History or presence of an abnormal ECG, which, in the opinion of the investigator, is clinically significant
Improving Health and Wellbeing for People Diagnosed With Chronic Spontaneous Urticaria (CSU)

This study aims to investigate the influence of psychosocial factors on Chronic Spontaneous Urticaria (CSU). Preliminary research suggests a potential link between stress and the experience of CSU symptoms. In light of these findings, our study offers a stress management intervention for individuals diagnosed with CSU.

The intervention consists of a 6-week online course designed to cultivate effective stress management techniques, referred to as 'attention-based training (ABT).' The course asks each participant to develop their own ABT practice, along with a one-hour session per week, providing techniques that participants can use to combat stressors related to their condition.

Chronic Spontaneous Urticaria (CSU) is a common disorder that is poorly understood and frequently misdiagnosed. The burden of the disease can include stress, anxiety, sleep disturbances, and difficulty with activities of daily living. Furthermore, psychological difficulties such as stress, may also aggravate the symptomatic burden of CSU. Holistic interventions are used as a complementary approach to alleviate symptoms in chronic diseases and may represent a valuable non-pharmacological approach in CSU. In 2021, Dr Padraic Dunne and colleagues published a feasibility assessment of an 8 week attention-based training programme to aid in the management of CSU \[1\]. Whilst this trial was deemed feasible and valuable for participants involved, further research was required with a wider sample to determine the role ABT may have in the management of the condition.

List of Aims and Objectives This current research aims to expand on their pilot study, and provide an evidence based non-pharmacological intervention to aid those in their management of CSU. This project will be the one of the first to provide CSU patients with a psychological intervention in conjunction with their clinical treatment. We believe that a combination of non-pharmacological and pharmacological solutions will ease the suffering caused by this condition and reduce the physical and fiscal burden on the Irish Health service and related clinics.

This study will 1.) Aim to identify the current psychosocial baseline of CSU patients attending urticarial clinics in Ireland and Scotland, to further highlight the psychosocial experience of this population. 2.) Provide and assess the effectiveness of an 6 week ABT programme for CSU management and patient wellbeing.

Eligibility Criteria:
Inclusion Criteria:

* Must have diagnosis of CSU

Exclusion Criteria:

* Classified as a vulnerable adult Cannot communicate online, in English
LORLATINIB-related HYPERLIPIDEMIA in ALK+ Non-Small Cell Lung Cancer

The goal of this observational study is to learn about the long-term effects of Lorlatinib related hyperlipidemia in NSCLC patients who take Lorlatinib for at least 21 days. The main question it aims to answer is:

* Whether blood lipids have been lowered down to an anticipated level within recommended range after the initial revealed Lorlatinib related hyperlipidemia?
* Will it be harmful to the cardiovascular system when blood lipids were not lowered down to normal levels in these cancer patients treated with Lorlatinib, i.e. major adverse cardiac events (MACE), or instead, carotid artery intima-media thickness.

Participants already taking Lorlatinib as part of their regular medical care for NSCLC will answer online survey questions.


Eligibility Criteria:
Inclusion Criteria:

* Advanced ALK+ NSCLC diagnosed by patholgy and/or cytology
* ECOG 0-2
* Age 18-80 years
* Taken Lorlatinib for at least 20 days
* Signed informed consent.

Exclusion Criteria:

* Treatment with other anti-cancer drugs during Lorlatinib treatment
Pharmaco-epidemiological Description of the Population Treated With Aptivus Under Market Conditions, Safety & Efficacy

To obtain information on clinical practices for patients treated by Aptivus in real life


Eligibility Criteria:
Inclusion Criteria:

* HIV positive patients for whom Aptivus treatment is initiated by their physician
* Aptivus SCP respect

Exclusion Criteria:

None if the inclusion criteria are respected: observational study
The Effects of an Anti-inflammatory Diet With or Without Curcumin Supplementation on Anthropometric Measurements, Concentrations of Thyroid Hormones, Anti-TPO, and Systemic Inflammation in Plasma and NFK-B in Peripheral Blood Mononuclear Cells in Patients With Hashimato

The goal of this clinical trial is to investigate The effects of an anti-inflammatory diet with or without curcumin supplementation on anthropometric measurements, concentrations of thyroid hormones, anti-TPO, and systemic inflammation in plasma and NFK-B in peripheral blood mononuclear cells in patients with Hashimoto.

The main questions it aims to answer are:

1. Does prescribing an anti-inflammatory diet with or without curcumin supplementation significantly affect the changes in anthropometric measurements (weight, body mass index, BMI, waist circumference, waist-to-hip ratio) in patients with Hashimoto's disease?
2. Does prescribing an anti-inflammatory diet with or without curcumin supplementation significantly affect the changes in the serum concentration of thyroid hormones (T3, T4, TSH) in patients with Hashimoto's disease?
3. Does prescribing an anti-inflammatory diet with or without curcumin supplementation significantly affect the change of Anti-TPO concentration in patients with Hashimoto's disease?
4. Does prescribing an anti-inflammatory diet with or without curcumin supplementation significantly affect the changes in systemic inflammation indicators (hs-CRP, IL-6) in plasma and NF-κB in peripheral blood mononuclear cells in patients with Hashimoto's disease?


Eligibility Criteria:
Inclusion Criteria:

Having Hashimoto's thyroiditis Willingness to cooperate Body mass index between 35 and 18.5 TSH less than ten and without clinical symptoms Not taking levothyroxine tablets

Exclusion Criteria:

Pregnancy and breastfeeding kidney Diseases Follow non-routine weight loss diets for three months before the start of the study × Taking slimming and fat-burning drugs, fiber powder Mineral, vegetable, and fiber vitamin supplements
The Effect of Novel High-intensity Interval Training on Physical Fitness in Older Adults

High-intensity interval training (HIT) has been demonstrated to be an effective strategy to improve markers of health and fitness across a wide range of healthy and clinical populations. Currently however, there is only limited evidence which has examined the effectiveness of HIT in older adults (\>50 years). HIT is an appealing strategy in this group as it has the potential to impact both cardiorespiratory and muscular fitness, which both play an important role in maintaining functional fitness and quality of life in a time-efficient manner. Developing an understanding of novel strategies for delivering this type of exercise training may ultimately provide a viable alternative to traditional modes of exercise training for a broader range of participants. As such, the purpose of this study is to evaluate the effects of a novel, high-intensity interval training exercise protocol to improve physical fitness in adults aged over 50 years. This research also aims to evaluate if this type of training intervention is feasible in this population, through analysis of adherence and intervention fidelity.


Eligibility Criteria:
Inclusion Criteria:

1. Must be aged 50-85 years
2. Must be able to provide informed consent to participate
3. Must be free from all exclusion criteria

Exclusion Criteria:

1. Symptoms of or known presence of heart disease of major atherosclerotic cardiovascular disease
2. Early family history of sudden cardiac death
3. Condition or injury or co-morbidity affecting the ability to undertake exercise
4. Diabetes mellitus
5. Pregnancy or likelihood of pregnancy
Study to Assess the Food Effect of K-877 in Healthy Adult Volunteers

Study is to assess the effects of food on the Pharmacokinetics(PK) of single-dose administration of K-877 in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subject provides written informed consent before any study-specific evaluation is performed;
* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at screening;
* Subject has a BMI of 18 to 30 kg/m2, inclusive, at screening
* Subject meets all inclusion criteria outlined in the clinical study protocol

Exclusion Criteria:

* Subject is a woman who is pregnant or breastfeeding;
* Subject has clinically significant abnormalities in the screening or check-in assessments;
* Subject has received an investigational drug within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug
* Subject does not meet any other exclusion criteria outlined in clinical study protocol.