cyrilzakka/clinical-trials huggingface dataset:
Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)

This study is being conducted at seven major children's hospitals in Australia and New Zealand to test a new approach for treating a virus, called cytomegalovirus in children with weakened immune systems. The researchers want to find out if using a web app to customise the dose of a medication called ganciclovir is better at clearing the virus over a six-week period compared to the standard method of giving the medication.

Immunocompromised children between 1 months to 18 years with cytomegalovirus viraemia who are admitted to one of the participating sites will be enrolled into the trial if eligible (see eligibility criteria) and randomly allocated into two groups. Children in the 'control- standard dosing group' will receive standard intravenous ganciclovir treatment for cytomegalovirus viraemia at a standard dosing of at 5mg/kg IV BD. Children in the "intervention: individualised dosing using a web app group" will receive a personalised intravenous ganciclovir dose calculated using an individualised IV ganciclovir dosing app. This approach considers the patient's weight, creatinine level, and target drug exposure, allowing for tailored dosing based on individual pharmacokinetic parameters. The virological clearance by 6 weeks of the children in each of the two groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. Immunocompromised patients including transplant recipients (haematopoietic stem cell transplant (HSCT), solid organ transplant (SOT)), those receiving chemotherapy or other immunosuppression or those with a known/suspected inborn error of immunity (determined by an immunologist); and
2. Detectable clinically significant CMV viraemia and treating clinician determines that antiviral therapy is indicated.
3. Willing to partake in the trial
4. Willing/able to attend all follow up visits and capable of completing all trial assessments.
5. Legally acceptable parent/guardian capable of providing consent on the participant's behalf.
6. Treating clinician agreeable to child being enrolled in the trial.

Exclusion Criteria:

1. Current or prior CMV infection with documented genotypic resistance to GCV (UL97 and/or UL54); or
2. Severe renal impairment (defined as estimated glomerular filtration rate (eGFR) \<25mL/min); or
3. Congenital CMV infection; or
4. Life expectancy of less than 7 days as determined by the treating physician; or
5. History of allergy, or adverse reaction to GCV, aciclovir or any component of the formulation; or
6. Treating clinician determines that combination antiviral therapy is indicated for CMV infection; or
7. Has received \>3 days of IV GCV or foscarnet or oral valganciclovir for the treatment of CMV infection prior to enrolment; or
8. Prior enrolment in the trial; or
9. Current recipient of another investigational product used for the treatment of CMV infection, as part of a clinical trial.
A Study to Compare LBVD to Eupenta and Imovax Polio in Healthy Adults

This is a single-center, randomized, active-controlled, parallel-group, open-label, phase I study to evaluate safety and immunogenicity of single injection of LBVD or Eupenta co-administered with Imovax Polio in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults between 19 and 55 years of age at the time of Visit 1 (Screening)
2. Persons who or whose legal representatives have voluntarily signed an informed consent after receiving explanation about the objectives, methods, effects, etc. of the clinical study
3. Persons who are surgically sterile, postmenopausal women, or agree to use contraceptive measures

Exclusion Criteria:

1. Persons who have an experience of participation in another interventional clinical study within 3 months prior to Visit 1 (Screening)
2. Persons who have a record of vaccination with the tetanus toxoid (TT)/tetanus diphtheria (Td)/tetanus diphtheria pertussis (Tdap) vaccine or other vaccines containing tetanus-diphtheria for adults or who are suspected to have been vaccinated with either of them within 5 years prior to Visit 1 (Screening)
3. Persons who were vaccinated within 4 weeks prior to Visit 1 (Screening) or who are scheduled to be vaccinated with the vaccines other than the study vaccine during the study period
4. Persons with a history of diphtheria, tetanus, pertussis, hepatitis B virus, polio virus, or the invasive diseases caused by Haemophilus influenzae type b
A Phase 1b Study Evaluating AMG 232 Alone and in Combination With Trametinib in Acute Myeloid Leukemia

Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute myeloid leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Men or women \> 18 years old
* Pathologically-documented, definitively-diagnosed AML that is relapsed or refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapy
* Ability to take oral medications and willing to record daily adherance to investigational product
* Adequate hematological, renal, hepatic, and coagulation laboratory assessments

Exclusion Criteria:

* Active infection requiring intravenous (IV) antibiotics
* Prior participation in an investigational study (procedure or device) within 21 days of study day 1
* Major surgery within 28 days of study day 1
* Anti-tumor therapy within 14 days of study day 1
Medication Misuse and Dependence Among Elderly

The project focuses on investigating problematic medication use, especially overuse of potentially addictive drugs among the elderly.

The investigators aim firstly to develop and validate instruments for detecting and describing behavioral aspects and consequences of dependence on, and misuse of, prescription medication among elderly.

In addition to evaluating diagnostic utility of screening instruments, the investigators aim to identify and report characteristics, risk factors and consequences of medication misuse and dependence among the elderly.

Elderly represent a particularly vulnerable group with many contributing factors including age-related multifactorial morbidity, cognitive function, polypharmacy, dependence and multiple prescribers with suboptimal communication. Centrally active pain killers and sedative/hypnotic medications give increased risk of addiction, adverse drug events, reduced physical and/or cognitive function.

The project comprises diagnostic accuracy, descriptive screening, cross-sectional and case-control studies, with aims to: i) assess diagnostic utility of instruments for elderly patients; ii) describe risk factors for medication misuse and dependence; iii) describe consequences of the use of centrally active medications among elderly compared to a control population.

Moreover, the investigators aim to examine the association between medication misuse and changes in cognitive function, focusing on deficits in specific domains of cognition. An additional aim is to explore the possibility of dissociating such cognitive changes from other causes of mild cognitive impairment (MCI) associated with development of dementia.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to geriatric or Neurology dept of hospital during inclusion time

Exclusion Criteria:

* MMSE \< 21,
* diagnosis of pre-existing severe depression or psychotic disease,
* pre-existing dementia diagnosis,
* new pain requiring start-up of central pain killers not previously used,
* Palliative treatment.
* Insufficient Norwegian language
* Serious visual disturbance and hearing impairment
* Strongly reduced general health precluding partcipation in interview and questionnaires
Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

The purpose of this study is to evaluate whether Biaxin (clarithromycin) improves sputum abnormalities, lung function, and overall feeling of well-being in people with cystic fibrosis (CF). Biaxin is an antibiotic commonly used for the treatment of respiratory infections in people who do not have CF, and is sometimes used in CF patients as well. Studies done in a disease called diffuse panbronchiolitis (which is similar to CF) and some preliminary studies that have been done in CF patients suggest that Biaxin might have a beneficial effect on CF sputum in ways unrelated to its antibiotic activity.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of CF
* ability to reliably perform spirometry
* FEV1 of 30% predicted at the time of screening

Exclusion Criteria:

* Mycobacterium in a sputum culture ever recorded
* a respiratory exacerbation requiring IV antibiotics in the 60 days prior
* used a investigational drug or device in the 60 days prior
* significant (\>30ml) of hemoptysis in the past year
* require oxygen or have significant liver or renal disease
The Ketogenic Diet for Pediatric Acute Brain Injury

This is a prospective pilot study evaluating the safety and feasibility of implementing the ketogenic diet in children admitted to the pediatric intensive care unit with acute brain injury such as stroke, traumatic brain injury, and intracerebral hemorrhage. Animal studies suggest that in the aftermath of injury the brain's ability to use glucose as a fuel is impaired. The ketogenic diet is a high fat, low carbohydrate diet which is already used in clinical practice for the treatment of medication resistant epilepsy and is intended to switch the body over to burning fat rather than carbohydrates for fuel. In lieu of their standard tube-feeds, 5-10 children admitted to the PICU with these diagnoses will receive low carbohydrate, high fat ketogenic feeds for 2 weeks. We hypothesize that ketones will be detectable through serum tests and MRI spectroscopy studies of the brain within several days of diet initiation, and that there will be a low incidence of side effects and adverse events,

Measures of interest will include the incidence of kidney stones, excessive acidosis and excessive hypoglycemia. The feasibility of implementing this protocol for a larger efficacy trial will be assessed through serial measurements of blood glucose, beta-hydroxybutyrate (a type of ketone body), and serum bicarbonate levels. In addition, levels of ketone bodies within the brain will be measured through MRI spectroscopy sequence which will be acquired at the same time as a follow-up MRI brain study ordered for clinical purposes.


Eligibility Criteria:
Inclusion Criteria: children age -17 years admitted to the pediatric intensive care unit with acute brain injury such as acute stroke, severe traumatic brain injury, and intracerebral hemorrhage

Exclusion Criteria:

1. True milk allergy (anaphylaxis or severe rash)
2. Significant gastrointestinal injury precluding enteral feeding
3. Hepatic or renal insufficiency
4. History of nephrolithiasis
5. Severe acidosis (serum bicarbonate ≤ 17 mEq/L) resistant to correction
6. History of inborn error of metabolism
7. Preexisting epilepsy or developmental delay
A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin

The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as injections under the skin


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body Mass Index (BMI) between 27.0 and 39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
* HbA1c equal to or greater than 6.5 % (48 mmol/mol) at screening
* Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:

  * Vitamin D (25-hydroxycholecalciferol) below 12 ng/mL (30 nM) at screening
  * Parathyroid hormone (PTH) outside normal range at screening
  * Total calcium outside normal range at screening
  * Amylase equal to or greater than 2 times upper limit of normal at screening
  * Lipase equal to or greater than 2 times upper limit of normal at screening
  * Calcitonin equal to or greater than 50 ng/L at screening
Prospective Randomized Trial On Radiation Dose Estimates Of CT Angiography In Patients Applying Iterative Image Reconstruction Techniques - The PROTECTION V Study -

The objective of this study is to compare a standard coronary CT angiography scan protocol with conventional image reconstruction with a scan protocol using reduced tube current and a new image reconstruction algorithm. The investigators hypothesize that the image quality of the new scan protocol is not inferior, while radiation dose estimates are reduced by around 30%.

Secondary endpoints of the study include quantitative image quality parameters, prevalence of non-diagnostic studies, prevalence of coronary artery plaques and plaque characteristics (calcified, non-calcified, mixed) and prevalence of follow-up examinations.


Eligibility Criteria:
Inclusion Criteria:

1. patients with an indication for a coronary CT angiography (planned evaluation of the coronary arteries)
2. signed informed consent
3. stable sinus rhythm
4. age \> 18 years

Exclusion Criteria:

1. known allergy to contrast agents.
2. patients with known coronary artery disease
3. pregnancy
4. no stable sinus rhythm
5. coronary ct examinations not focussing on coronary arteries
Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial Matrix Metalloproteinases

The purpose of this study is to compare the effects (good and bad) of subantimicrobial dose doxycycline on the irregular bleeding women experience when taking continuous oral contraceptive pills. This research is being done because currently, there is no effective treatment for this condition. Findings from this study could help to decrease the side effects of birth control pills and decrease unplanned pregnancies.

Continuous oral contraceptive administration entails women taking hormonally active pills for 28 days without a seven day placebo week to avoid hormonal withdrawal bleeding. Unfortunately, with continuous administration, timed, regular bleeding can be replace by irregular, unscheduled bleeding, which often leads to dissatisfaction, discontinuation and the possibility of unplanned pregnancy.

Matrix Metalloproteinases, a group of zinc-dependant proteases, are hypothesized to play a role in endometrial degradation. The purpose of this study is to describe the expression of Matrix Metalloproteinases in endometrial biopsy specimens collected 1) prior to initiating oral contraceptives 2) while taking cyclic oral contraceptive 3) while taking continuous oral contraceptives and 4) while taking continuous oral contraceptives along with sub-antimicrobial doxycycline.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages 18 and 45 who are ovulatory as demonstrated by a pre-treatment Progesterone (P) greater than or equal to 3.0 ng/mL prior to oral contraceptive use

Exclusion Criteria:

* Women with any absolute contraindications to ethinyl estradiol and levonorgestrel;
* Women who are pregnant or breastfeeding
* Use of oral contraceptives, patch, ring, intrauterine or implantable hormonal contraception within 4-weeks;
* Medroxyprogesterone acetate use within six months;
* Current use of drugs that interfere with sex steroid metabolism.
Measuring the HIV-1 Reservoir During Cure Interventions Studies (MERCI)

The aim of this study is the gain new insights into HIV latency before and after cure intervention studies through extensive blood and tissue sampling (lymph node and colon biopsies) from 30 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Meets the inclusion criteria of the cure intervention study

Exclusion Criteria:

* Current history of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification), consisting of chronic HIV-1 infection.
* Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent seroconversion (=HBV antigen or viral load negative and positive HBV surface antibody)).
* Evidence of active HCV infection (HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV antibody result is negative, a positive HCV RNA result within 60 days prior to study entry).
* Current or known history of cardiomyopathy or significant ischemic or cerebrovascular disease.
* Current history of cancer.
* History of HIV-related thrombocytopenia.
* Pregnancy or breastfeeding.
* Any condition, including preexisting psychiatric and psychological disorders, which will in the opinion of the investigator interfere with the trial conduct or safety of the participant.
* Abnormal results of standard of care laboratory tests:

  1. Confirmed haemoglobin \<11g/dl for women and \<12 g/dl for men
  2. Confirmed platelet count \<100 000/µl \*
  3. Confirmed neutrophil count \<1000/μl
  4. Confirmed AST and/or ALT \>10xULN
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Acute or serious illness, in the opinion of the site investigator, requiring systemic treatment and/or hospitalization within 60 days prior to entry.
* The following treatment will be prohibited three months before screening and during the study:

  1. immunosuppressive drugs (inclusive corticosteroids) except for drugs used for topical use.
  2. Immunomodulatory drugs including but not limited to Granulocyte-colony stimulating factors, Granulocyte-monocyte colony-stimulating factor, interleukin 2, 7 \& 15.
Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma

This is a Phase 2b, global, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig in adult participants aged 18 to 80 years, (inclusive) with moderate-to-severe asthma.


Eligibility Criteria:
Inclusion Criteria:

* A physician-diagnosed moderate-to-severe asthma for ≥12 months based on GINA guidelines Steps 4 and 5
* Participants with existing treatment with moderate-to-high doses of ICS therapy for in combination with at least 1 but no more than 2 additional controller medications at least 3 months with a stable dose ≥1 month prior to Visit 1
* At least 1 asthma exacerbation in the past year, with at least one exacerbation occurring while on treatment with moderate to high doses of ICS therapy
* ACQ-5 score more than 1.5 at Screening (Visit 1)

Exclusion Criteria:

* Chronic obstructive or other lung diseases (eg, COPD, idiopathic pulmonary fibrosis, etc) which may impair lung function, or another diagnosed pulmonary or systemic disease.
* Current smoker or former smoker with cessation within 6 months of Screening or history of \>10 pack-years. Active vaping of any products and/or marijuana smoking within 6 months of Screening.
* Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening
* Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening
* For participants on chronic OCS use for the maintenance treatment of asthma: history of a serious infection requiring hospitalization within the past 12 months prior to Randomization (Visit 2).
* Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening
* Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease
* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Intradialytic Aerobic Exercise in CKD Patient

Intradialytic aerobic exercise is not effective in increasing hemodialysis adequacy but is effective in improving physical performance in twice-weekly hemodialysis patients.

Uremic myopathy occurs in 60-75% of Chronic Kidney Disease (CKD) patients undergoing hemodialysis, which causes a decrease in muscle strength and physical performance. Increasing dialysis adequacy is beneficial in reducing the impact of uremia on muscles. Intradialytic aerobic exercise in thrice-weekly hemodialysis patients has improved dialysis adequacy and physical performance. This study aims to determine the effect of intradialytic aerobic exercise on improving dialysis adequacy and physical performance in twice-weekly hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* End Stage Renal Disease Patient stage 5 with Glomerular Filtration Rate \<15mL/minute/1.73m2 aged 25-54 years undergoing hemodialysis two times per week for three months to five years
* Hemoglobin levels \> 8mg/dl
* Mini-Mental State Examination (MMSE) score of ≥24
* Hamilton Depression Rating Scale (HDRS) score \<25

Exclusion Criteria:

* Received aerobic exercise in the last 3 months
* History of hospitalization in the last 3 months
* Access for hemodialysis circulation via the femoral vein.
* IMT \<18,5 (underweight) dan ≥35 (obese class II)
* Non-stable cardiovascular disease, uncontrolled glucose, acute infection disease
Perioperative Evaluation of MMP-9-TIMP-1 System in Vascular Surgery Regarding Ischemic-reperfusion Injury

The MMP-9-TIMP-1 system has been implicated in many physiological and pathophysiological conditions including vascular surgery related ischemic-reperfusion injury. Our key aims were to establish the early perioperative time courses of the aforementioned system in aorto-bifemoral bypass and aorta stentgraft implantation procedures and to find correlation between the MMP-9-TIMP-1 system and the cross-clamp time. Patients were prospectively enrolled after Ethical Committee approval. Blood samples were taken at four different time points (T1-4): T1: right before surgery, T2: 60 min after the cross-clamp release, T3: first postoperative morning, T4: third postoperative morning. Plasma was isolated from heparin anticoagulated blood samples by low speed centrifugation at 4 °C, and stored at -80 °C until analyzed in a single batch at the end of the study. MMP- 9 and TIMP-1 were determined by the quantitative sandwich enzyme-linked immunosorbent assay (ELISA) techniques according to the manufacturer instructions (R\&D Systems Inc., Minneapolis, Minnesota, USA). In comparison with standard curves, the concentrations of MMP-9 and TIMP-1 in plasma were determined spectrophotometrically (Multiskan Ascent microplate photometer, Type: 354, Thermo Electron Corporation, Waltham, Massachusetts, USA) by reading the absorbance at 450 nm. Plasma concentrations of MMP-9 and TIMP-1 were expressed as ng/ml.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective procedure (aorto-bifemoral bypass or aorta stentgraft implantation) by vascular surgeons.
* Over age 18
* agree to participate

Exclusion Criteria:

* under age 18
* refuse to participate
* diagnosed malignant disease
* chronic steroid usage
* being on cytostatic therapy