cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Emapalumab in Adult Patients With HLH

Hemophagocytic lymphohistiocytosis (HLH) is a rare, life-threatening condition characterized by uncontrolled hyperinflammation which may develop on the background of several clinical conditions (e.g. autoimmune disease, infection, malignancy). Emapalumab (previously referred to as NI-0501) is a monoclonal antibody neutralizing interferon-gamma (IFN-gamma), a key cytokine driving the inflammation and tissue damage seen in HLH. The purpose of this study is to assess the efficacy, safety and pharmacokinetics of emapalumab in adult patients with secondary HLH.

Study NI-0501-10 is an open-label, single arm, multicenter, Phase 2/3 interventional study.

The study enrolls adult patients with hemophagocytic lymphohistiocytosis (HLH), specifically newly diagnosed patients with malignancy-associated HLH (M-HLH), and newly diagnosed or previously treated patients with non-malignancy-associated HLH.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients of age 18 and older at the time of HLH diagnosis
* Fulfilment of 5 of the 8 HLH-2004 clinical criteria
* Patients diagnosed with malignancy-associated HLH must be treatment naïve; patients diagnosed with HLH driven by any other etiology or idiopathic can be either treatment naïve or treatment experienced
* Patients with non-malignancy-associated or idiopathic HLH who have already received conventional therapy for HLH must have failed prior treatment as per the treating physician's judgement
* Informed consent signed by the patient or by the patient's legally authorized representative(s) (as required by local law)
* Willing to use highly effective methods of contraception from study drug initiation to 6 months after the last dose of study drug, if female and of childbearing potential.

Exclusion Criteria:

* Primary HLH
* Current or scheduled administration of therapies known to trigger the cytokine release syndrome (e.g. chimeric antigen receptor (CAR)-modified T cells, bispecific T cell-engaging antibodies)
* Current or scheduled administration of PD-1/PD-L1/CTLA-4 inhibitors
* Life-expectancy associated with the underlying disease (triggering HLH) \< 3 months
* Ongoing participation in an investigational trial, or administration of any investigational treatment within 30 days
* History of hypersensitivity or allergy to any components of emapalumab
* Active mycobacteria, Histoplasma capsulatum, or Leishmania infections
* Evidence of latent tuberculosis
* Receipt of a bacille Calmette-Guerin (BCG) vaccine within 12 weeks prior to Screening
* Receipt of a live or attenuated live (other than BCG) vaccine within 6 weeks prior to Screening
Effect of Noise Isolation on the Incidence of Moderate to Severe Postoperative Pain

To investigate the effect of noise isolation during general anesthesia on the incidence of moderate to severe postoperative pain in patients undergoing major abdominal surgery. The aim of this study was to determine whether noise isolation can reduce the Incidence of moderate to severe postoperative pain and analgesic use.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 70, both male and female.
* American Society of Anesthesiologists Classification 1-3
* Patients undergoing elective major abdominal surgery under general anesthesia(Surgery time ≥ 2h)
* Voluntarily accept patient controlled intravenous analgesia and signed informed consent

Exclusion Criteria:

* Patients with previous severe disease
* Patients with hearing abnormalities
* Patients requiring mechanical ventilation or undergoing epidural catheters or other types of regional anesthesia after surgery
* Patients with chronic preoperative pain and/or long-term analgesic use
* Patients who could not cooperate with the study for any reason
PET With [18F]HX4 in Head and Neck Cancer

The aim of this study is to (i) Determine if tumor hypoxia can be accurately visualised with \[18F\] HX4 PET imaging in head and neck tumors (ii) correlate the \[18F\] HX4 PET images with blood and tissue markers and (iii) investigate the quality and optimal timing of \[18F\] HX4 PET imaging (iv) compare \[18F\] HX4 PET uptake with \[18F\] FDG PET uptake before and after treatment.

Tumor hypoxia is the situation where tumor cells are or have been deprived of oxygen. Hypoxic tumor cells are usually more resistant to radiotherapy and chemotherapy and more likely to develop metastasis. In head and neck cancer, tumor hypoxia is known to be an important prognostic factor for long term survival. \[18F\]HX4 is being developed as a diagnostic radiopharmaceutical for PET imaging to find a marker for hypoxia that can be used in standard clinical practice. Current hypoxia tracers lack reliable image quality and kinetics. Because of the short half life and clearance, we expect that \[18F\]HX4 will have a higher tumor to background ratio than current nitro-imidazole hypoxia markers such as \[18F\]-misonidazole. The clinical use of a reliable, non-invasive and easy to use hypoxia imaging agent could allow selection of patients most likely to benefit from hypoxia modifying therapies.

Included are eligible patients with head and neck squamous cell carcinoma (T2, T3, T4, any N, M0) with tumor diameter ≥ 2,5 cm of the oral cavity, oropharynx, hypopharynx or larynx, planned to be treated with curative primary radiation treatment (+/- concurrent chemotherapy). Before treatment a standard planning \[18F\]FDG PET-CT will be performed, a blood sample is drawn and baseline \[18F\]HX4 PET scans will be performed. 18F-HX4 scans will be repeated after radiotherapy treatment with 20 +/- 4 Gy (approximately two weeks). Three months after the end of treatment a \[18F\]FDG PET scan will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmed HNSSC of the oral cavity, oropharynx, hypopharynx, larynx, T2-T3-T4, any N, M0
* Tumor diameter ≥ 2,5 cm
* WHO performance status 0 to 2
* Scheduled for primary curative (concurrent chemo-) radiotherapy
* No previous surgery to the head and neck
* No previous radiation to the head and neck
* Adequate renal function (calculated creatinine clearance at least 60 ml/min).
* The patient is willing and capable to comply with study procedures
* 18 years or older
* Have given written informed consent before patient registration

Exclusion Criteria:

* No recent (\< 3 months) myocardial infarction
* No Uncontrolled infectious disease
* Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
Noninvasive Evaluation of Renal Allograft Fibrosis by MRI

The purpose of this study is to validate an MRI method to detect renal fibrosis in patients after kidney transplantation (KT).

The hypothesis underlying this proposal is that qMT reliably detects development of allograft fibrosis in human subjects after KT. To test this hypothesis, the qMT-derived bound pool fraction will be correlated with renal fibrosis as per biopsy in 20 patients 4 or 7 years after living donor KT. The bound pool fraction will also be compared to renal blood flow, oxygenation, and function, and the ability of qMT to provide consistent assessments of fibrosis tested at different magnetic field strengths. Two specific aims will test the hypotheses that: Specific Aim 1: qMT provides reliable and consequential assessment of fibrosis in human kidney allografts. Specific Aim 2: Renal fibrosis assessed by qMT in human kidney allografts is reproducible at 1.5 T and 3.0 T.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Recipient of living donor kidney transplantation 4 or 7 years earlier
* Competent and able to provide written informed consent; Ability to comply with protocol

Exclusion Criteria:

* Patients have clinically significant medical conditions within the prior 6 months before: e.g. myocardial infarction, congestive heart failure, stroke, that would, in the opinion of the investigators, compromise the safety of the patient.
* Severe chronic liver, heart or lung disease
* Undergoing acute rejection
* Contra-indication to biopsy; bleeding disorders
* Chronic infection
* Any active malignancy and undergoing therapy
* Kidney or ureteric stone
* Unable to give valid informed consent
* Known pregnancy or intent to conceive during the study period
* Pacemaker, implantable defibrillator, magnetically active metal fragments, claustrophobia or other contraindication to MRI
* Federal medical center inmates.
* Latex allergy
Effect of Antenatal Education on Knowledge,Attitude and Preferences Taward Delivery Modes

The aim of the current study is to assess the effect of antenatal education on pregnant women's knowledge, attitude, and preferences of delivery mode.

This study employed a quasi-experimental design with intervention and control group. The purposive sample will consisted of 140 pregnant women who attended for prenatal care for follow up at the previously mentioned setting. The main objective of the study will to examine the effect of antenatal education on pregnant women's knowledge, attitude, and preferences toward the mode of delivery.

In order to accomplish the study's aim, the following research hypothesis is developed:

Hypothesis 1. Pregnant women who receive antenatal education will have a higher level of knowledge and positive attitude regarding the mode of delivery than those in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who are 18 to 35 years old.
* A singleton pregnancy in the third
* Primigravida and pregnant women with a history of one prior elective cesarean section at least two years between pregnancies.

Exclusion Criteria:

* Pregnant women who has any indication of a cesarean section or obstetrical issues that have arisen during the present pregnancy
* Pregnant woman who suffer from psychological illness.
Imaging 61CuATSM Uptake in Atherosclerotic Plaque Using PET-CT

The build up of plaque in the wall of the artery supplying blood to the brain poses a risk of stroke when the plaques become unstable and fragile. It is important to determine which patients are most at risk so that surgery can be performed. There is evidence that the risk is greatest when these plaques become oxygen deficient (hypoxic). The investigators wish to use PET imaging to identify hypoxic plaque, to help decide whether and when to perform surgery. The investigators have developed radiotracers (imaging agents) for this purpose, and this study is to determine whether they will work in patients.


Eligibility Criteria:
Inclusion Criteria:

* Male/Female patients who are 55yrs or older and for whom carotid endarterectomy is clinically indicated and a decision has been made to perform a carotid endarterectomy.
* Normal liver and adequate renal function. Assessed by measuring eGFR (\>50ml/min) and creatinine (\<130μmol/L)
* Life expectancy \> 12 weeks
* Patients should be able to tolerate head/neck mask as well as lying in the PET-CT scanner

Exclusion Criteria:

* Abnormal liver and renal function (eGFR \<50ml/min, Creatinine \>130μmol/L)
* Patient unwilling to provide written informed consent
Subconjunctival Injection of Triamcinolone Acetonide and Limited Peritomy During Pterygium Excision

Pterygium is characterized by encroachment of a ﬂeshy fibrovascular tissue from the bulbar conjunctiva on to the cornea. Although previously thought to be a solely degenerative disease, a new evidence has demonstrated the role of cell proliferation and inflammation in the pathogenesis of pterygium , and also by the clinical data that steroids are beneﬁcial in halting progression of impending recurrent pterygium . Many techniques have been developed for pterygium surgery over time. The simple method of removing the head and body of pterygium and leaving the sclera uncovered, the so-called bare-sclera technique, has been associated with high recurrence rates of 32-88% . To reduce the recurrence rate after pterygium surgery with a bare-sclera technique, various adjunctive modalities have been used such as chemical agents including mitomycin C , 5-ﬂuorouracil . Furthermore, when removal of pterygium is accompanied with a graft, such as conjunctival autograft or amniotic membrane transplantation , lower recurrence rates have been achieved . However, it remains unclear why the bare sclera technique has poorer outcome with higher recurrence rate than other procedures.

One of the factors that may have a role in the outcome of pterygium surgery is postoperative conjunctival inflammation , treatment of which has been demonstrated to improve the ﬁnal outcome . It has been shown that persistent conjunctival inflammation around the surgical site after pterygium surgery is present in 31-84% of cases with amniotic membrane transplantation, and in 15% of eyes with conjunctival autograft . However, the rate of conjunctival inflammation after pterygium surgery with a bare-sclera technique has not been reported in literature . Also, it has been suggested that higher recurrence rate after pterygium with amniotic membrane transplantation compared with conjunctival autograft may be due to higher rate of postoperative conjunctival inflammation . Therefore, it may be speculated that higher recurrence rate after pterygium surgery with a bare-sclera technique is partly due to higher rate of postoperative conjunctival inflammation .

Eligibility Criteria:
Inclusion Criteria:

* primary pterygium.

Exclusion Criteria:

* preexisting glaucoma .
* patient with family history of glaucoma
Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management

The goal of this study is to test whether a dipeptidyl peptidase-4 inhibitor, compared with a sulfonylurea, improves time in normal blood glucose range and reduces blood glucose variability. Blood glucose is measured using a continuous glucose monitoring device.

This is a proof-of-concept clinical trial testing the effects of linagliptin versus glipizide on glucose variability among people with type 2 diabetes and stage 3-4 CKD. In a cross-over design, each enrolled participant will receive 28 days of each study medication. Study medications will be provided in a randomly assigned order without blinding. The primary study outcome is glucose time in range, measured by blinded continuous glucose monitoring for the last 6 days of each 28-day treatment period. Secondary outcomes include indices of glycemic variability, hypoglycemia, and biomarkers of systemic inflammation, oxidative stress, and albuminuria. The overall goal of this research is to identify safe and effective treatments to control glycemia among patients with diabetes and CKD.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* eGFR 15-59 mL/min/1.73 m2
* Hemoglobin A1c \< 8%
* Age ≥ 18 years
* Current use of sulfonylurea

Exclusion Criteria:

* BMI \> 40 kg/m2
* Actively using CGM for clinical care
* End stage renal disease needing dialysis
* Kidney transplant
* Pregnant or nursing
* Unable to provide informed consent
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus

The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for the treatment of Type 1 Diabetes Mellitus (T1DM) in basal-bolus therapy.

Criteria for randomization into the study included 1) fasting blood glucose and predinner glucose values in the range of 70 to 140 milligrams per deciliter (mg/dL) approximately 60% of the time for 7 days prior to randomization 2) 90 minute or 2-hour postprandial blood glucose \<220 mg/dL approximately 70% of the time for 7 days prior to randomization and 3) successfully completed 3 days of 10-point glucose monitoring and have at least 4 self-monitored blood glucose values on all non-10-point monitoring days. Participants that did not meet 1 or more of these criteria during a 4- to 6-week Titration Period were not randomized.

Eligibility Criteria:
Inclusion Criteria:

* Males or females aged ≥18 years
* Type 1 Diabetes Mellitus (T1DM) treated with insulin for ≥12 months
* Body mass index (BMI) 18.0 to 40.0 kilograms per square meter (kg/m\^2).
* Hemoglobin A1C (HbA1C) level 6.7% to 8.2%, inclusive
* Fasting C-peptide \<0.6 nanograms per milliliter (ng/mL)
* Willingness to use twice daily (BID) insulin glargine as basal insulin for the duration of the study
* Willingness to avoid use of an insulin infusion pump or unblinded continuous glucose monitoring (CGM) during the study

Exclusion Criteria:

* Known or suspected allergy to any component of any of the study drugs
* Use of pramlintide within 30 days of Screening
* Use of drugs during the study or within 30 days of Screening (such as corticosteroids or antimetabolites) that could interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia
* Recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the Investigator
Psychological Impact of COVID-19 on Intensive Care Survivors

Psychological distress is commonly experienced by survivors of an intensive care admission, including patients treated during previous pandemics. Whilst data emerges about the short-term impact of COVID-19 on patients and healthcare systems, the long term impact remains unclear.

The purpose of this trainee-led, multi-centre longitudinal study is to assess the short- and long-term psychological impact on patients who have survived an admission to intensive care due to COVID-19, and identify possible predictors of anxiety, depression and trauma symptoms in this patient group.

The primary objective is to identify the proportion of patients surviving an admission to intensive care due to COVID-19 who experience anxiety, depression and/or trauma symptoms in the 6 months post discharge.

Whilst the secondary objectives are to identify demographic, clinical, physical and/or psychosocial predictors of depression, anxiety and/or trauma symptoms at 3-, 6- and 12-months post discharge from ICU. And to assess the feasibility of using a self-reported online questionnaire to assess anxiety, depression and/or trauma symptoms in patients following ICU admission.

An amendment was approved by the East Midlands - Derby Research Ethics Committee on 17 March 2022, to conduct three sub-studies:

1. Semi-structured interviews - to explore the experiences of critical care survivors following COVID-19 infection during their recovery phase, including perceptions about the care received and support available to them.
2. Survey of follow-up services offered to ICU survivors - to assess geographical differences in the availability and structure of follow-up services offered to patients with critical COVID-19 after hospital discharge.
3. Survey of study team members - to gain feedback from the study team members on their involvement in the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥18 years
* Survival to intensive care / high dependency unit discharge following an admission of ≥24 hours
* Treated for COVID-19

Exclusion Criteria:

* Unable to complete questionnaires
* Unable or unwilling to consent
* Unable to speak, understand or communicate in English
* Patients with diagnosed, pre-existing cognitive impairment (at the time of ICU admission)
* Patients without a fixed abode, at which postal questionnaires might be received, and who have no access to a personal email address.
EHealth Intervention to Manage Depression and Anxiety in Patients with Ischemic Heart Disease

This study evaluates the effectiveness and cost-effectiveness of a therapy-assisted internet-based intervention in patients with ischemic heart disease and co-morbid depression and anxiety referred for cardiac rehabilitation. Half of the patients will receive the intervention and the other half usual care. We hypothesize that the intervention will lead to a reduction in patients' symptoms of depression and anxiety and be cost-effective.

The 12-week intervention will consist of 9 modules and 2 optional modules that will be delivered to patients in the active intervention via a platform or app. Psychologists will provide asynchronous guidance via the platform. Motivational interviewing will be used during the intervention to prevent dropout. The psychologist may contact patients via telephone during the intervention if needed. All patients will have access to the intervention up to 6 months' post intervention so that they can revisit the material and reuse it on a need-to-basis. Patients will be recommended to use this option and to note specific time points in their agenda where they will access the intervention. A brief purpose-designed interview protocol that includes elements from the SCAN interview will be carried out by psychologists trained in conducting the interview.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of ischemic heart disease (diagnostic codes I20-I25)
* Referred for CR
* HADS score ≥ 8 on depression and or anxiety
* Access to a computer or smart phone
* Ability to use computer or smart phone
* Proficient in the Danish language
* Signing an informed consent form

Exclusion Criteria:

* Severe psychiatric disorder (i.e., borderline disorder, schizophrenia or bipolar disorder)
* Severe cognitive difficulties (e.g. severe brain damage, mental retardation, or dementia) that will prevent patients from participating
* Endorsement of suicidal ideation with daily suicidal thoughts (PHQ-9 item 9 \>2)
* Participation in other intervention studies (unless they are clinical studies)
* Seeing a psychologist or mental health professional for the treatment of anxiety and depression